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This is a prospective, observational, online study of people diagnosed with ALS, MND or PLS referred to as HAROS (Healing ALS Registry Observational Study). Participants will enter information into an online ALS registry once per month, including their ALSFRS-R data, certain other symptoms, dietary intake, supplements, medications and other therapies, both conventional and integrative. Participants will also enter the hours spent on optional self-study and free online education. The investigators will assess the effectiveness of various therapies and education by measuring physical outcomes.
There is strong evidence that Amyotrophic Lateral Sclerosis (ALS), Motor Neuron Disease (MND) and Primary Lateral Sclerosis (PLS) are potentially reversible and NOT uniformly-fatal conditions, as reported in the literature. A 12-month 2024 retrospective, observational registry data analysis of 45 ALS patients showed that 85% did better than predicted in the peer-reviewed published literature. In fact, 20% did not lose functionality and 20% actually improved functional status over 12 months.
This prospective study seeks to enroll at least 1000 patients diagnosed with ALS, MND or PLS confirmed by their neurologist into this fully-remote, larger, observational study to see if the results of the 45-person ALS data analysis can be substantiated with a larger number of ALS, MND and PLS participants. Participants will be from the USA and other countries. In addition to that primary purpose, the investigators expect to:
Study participants commit to updating their information monthly into the online registry for at least one year, preferably for up to 10 years. This takes approximately one hour per month. Participants choose their own treatment protocols based on their own research and input from their healthcare practitioners. Self-study and integrative medicine education is optional but encouraged. Participants in this study can join other research studies at the same time as HAROS, as long as they record in the registry all studies in which they are participating.
This study (HAROS) has the potential to improve the prognosis of patients with a diagnosis of ALS, MND or PLS when results are periodically shared about the effectiveness of various treatments and education.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALS/MND less than 3 years since diagnosis | Those diagnosed with ALS, Amyotrophic Lateral Sclerosis or MND, Motor Neuron Disease (other countries) and time since diagnosis is less 3 years, or 36 months, as of the date they join the study. |
| |
| PLS less than 3 years since diagnosis | Those diagnosed with PLS, Primary Lateral Sclerosis, and time since diagnosis is less 3 years, or 36 months, as of the date they join the study. |
| |
| ALS/MND 3 years or greater since diagnosis | Those diagnosed with ALS, Amyotrophic Lateral Sclerosis or MND, Motor Neuron Disease (other countries) and time since diagnosis is 3 years or greater as of the date they join the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education about treatment options | Other | Education about treatment options and integrative therapies is optional. It is available online and is free for all study participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ALSFRS-R ALS Functional Rating Scale - Revised | ALS Functional Ratings Scale is a set of 12 questions, with a maximum of 4 points per question and measures physical functionality. Outcomes are measured at a point in time and range from 0 for no functionality to 48 for full functionality in all areas measured. The higher the score the better the outcome. | Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| ALSSQ ALS Supplementary Questionnaire | ALS Supplementary Questionnaire (ALSSQ) is a measure of physical functionality and symptoms that are not measured in the ALSFRS-R scale. Items measured in the ALSSQ are energy level, sleep quality and quantity, pain, fasciculations, muscle cramps, mucous, mental clarity, head drop and showing emotions inappropriately. There are 18 questions, 4 points each, for a maximum of 72 points. The higher this score, the better the outcome. | Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Mindset Score | Mindset is measured by questions about A) positivity, maximum 400 points, B) belief in ability to get well and mental blocks to healing, maximum 18 points, and C) a Modified PANAS (Positive and Negative Affect Schedule), maximum of 50 positive points and 50 negative points. The investigators will analyze how these measures of mindset correlate with ALS/MND/PLS outcomes. | Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Body Weight is often an issue with ALS/MND/PLS patients. The investigators will observe any correlation between body weight and outcomes. | Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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The investigators are studying adult non-smokers who have a diagnosis of ALS, MND or PLS, irrespective of time since diagnosis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Healing ALS Study Administrator | Contact | 1-973-714-4621 | Study@HealingALS.org |
| Name | Affiliation | Role |
|---|---|---|
| William L Cowden, MD | Chair of Scientific Board of Academy of Comprehensive Integrative Medicine, Co-chair of Medical Advisory Team of Healing ALS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virtual | Recruiting | Park City | Utah | 84098 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33468103 | Background | Boddy SL, Giovannelli I, Sassani M, Cooper-Knock J, Snyder MP, Segal E, Elinav E, Barker LA, Shaw PJ, McDermott CJ. The gut microbiome: a key player in the complexity of amyotrophic lateral sclerosis (ALS). BMC Med. 2021 Jan 20;19(1):13. doi: 10.1186/s12916-020-01885-3. | |
| 33068316 | Background | Peters S, Broberg K, Gallo V, Levi M, Kippler M, Vineis P, Veldink J, van den Berg L, Middleton L, Travis RC, Bergmann MM, Palli D, Grioni S, Tumino R, Elbaz A, Vlaar T, Mancini F, Kuhn T, Katzke V, Agudo A, Goni F, Gomez JH, Rodriguez-Barranco M, Merino S, Barricarte A, Trichopoulou A, Jenab M, Weiderpass E, Vermeulen R. Blood Metal Levels and Amyotrophic Lateral Sclerosis Risk: A Prospective Cohort. Ann Neurol. 2021 Jan;89(1):125-133. doi: 10.1002/ana.25932. Epub 2020 Nov 6. |
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Individual participant data that underlie the results reported in the published article, after de-identification (text, tables, figures and appendices)
The investigators will share IPD starting 1 year after publication and will make it available for 3 years from that date.
Researchers who provide a methodologically sound proposal as assessed by our Scientific Advisory Team.
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| PLS 3 years or greater since diagnosis. | Those diagnosed with PLS, Primary Lateral Sclerosis and time since diagnosis is 3 years or greater as of the date they join the study. |
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| Dietary Supplements: Vitamins, Minerals, Herbs, etc. | Dietary Supplement | The investigators are observing type and quantity of dietary supplements, vitamins, minerals and herbs that ALS/MND/PLS patients take regularly. |
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| Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc. | Behavioral | Many of those diagnosed with ALS/MND/PLS regularly engage in meditation, prayer and other behavioral protocols. These will be observed and analyzed to see if, and to what degree they affect outcomes. |
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| Diet, various diets will be observed | Other | May ALS/MND/PLS patients follow a specific diet such as ketogenic, vegetarian, gluten-free, dairy-free, and/or sugar-free. The investigators will analyze which diets are most efficacious. |
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| Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapies | Other | Exercise, physical therapy, occupational therapy, speech therapy, sauna, massage, EMS (electro-muscular stimulation), red light therapy and other physical modalities will be observed and analyzed for effect on outcomes. |
|
| ALS medications and other medications | Drug | Many ALS/MND/PLS patients find benefit from prescription and other drugs. These will be observed and analyzed for effect on quality of life and outcomes. |
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| Physical and emotional support | Other | Study participants are asked to record the level of emotional and physical support they get from family members, caregivers, friends, medical professionals and members of their community. The investigators will analyze how the perceived level of emotional and physical support affect outcomes. |
|
| Change in blood inflammation markers Set 1 | All lab tests are optional, and ordered through the patient's physician and recorded. Inflammation and neuroinflammation are often associated with ALS/MND/PLS. Higher inflammatory markers may be correlated with faster disease progression. The investigators will analyze how these measures correlate with ALS/MND/PLS outcomes. NfL plasma (Neurofilament Light chain - plasma) pg/mL NfL serum (Neurofilament Light chain - serum) pg/mL Interleukin-6 pg/ml TMAO (Trimethylamine-N-Oxide) pg/mL | Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood inflammation markers Set 2 | All lab tests are optional, and ordered through the patient's physician and recorded. Inflammation and neuroinflammation are often associated with ALS/MND/PLS. Higher inflammatory markers may be correlated with faster disease progression. The investigators will analyze how these measures correlate with ALS/MND/PLS outcomes. hs-CRP (high sensitivity C-Reactive Protein) mg/dL GGT (gamma-glutamyl transferase) mg/dL | Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood oxidative stress markers Set 1 | All lab tests are optional, and ordered through the patient's physician. Higher oxidative stress may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
| Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood oxidative stress markers Set 2 | All lab tests are optional, and ordered through the patient's physician. Higher oxidative stress may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. a. Serum malondialdehyde measured in nmol/mL | Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood essential nutrient levels Set 1 | All lab tests are optional, and ordered through the patient's physician. Levels of essential nutrients may be associated with faster or slower disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
| Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood essential nutrient levels Set 2 | All lab tests are optional, and ordered through the patient's physician. Levels of essential nutrients may be associated with faster or slower disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. a. Vitamin D-25 Hydroxy (ng/mL) | Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood essential nutrient levels Set 3 | All lab tests are optional, and ordered through the patient's physician. Levels of essential nutrients may be associated with faster or slower disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
| Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood essential nutrient levels Set 4 | All lab tests are optional, and ordered through the patient's physician. Levels of essential nutrients may be associated with faster or slower disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
| Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood essential nutrient levels Set 5 | All lab tests are optional, and ordered through the patient's physician. Levels of essential nutrients may be associated with faster or slower disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
| Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood insulin resistance markers Set 1 | All lab tests are optional, and ordered through the patient's physician. Insulin resistance may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
| Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood insulin resistance markers Set 2 | All lab tests are optional, and ordered through the patient's physician. Insulin resistance may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. a. HDL Cholesterol (mg/dL) (lower indicates higher level of insulin resistance) | Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood insulin resistance markers Set 3 | All lab tests are optional, and ordered through the patient's physician. Insulin resistance may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. a. Fructosamine, fasting (µmol/L) (higher indicates higher level of insulin resistance) | Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood insulin resistance markers Set 4 | All lab tests are optional, and ordered through the patient's physician. Insulin resistance may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. a. Hemoglobin A1C (percent) (higher indicates higher level of insulin resistance) | Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood infection markers Set 1 | All lab tests are optional, and ordered through the patient's physician. Infection markers in the blood may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. A higher IgG indicates a higher level of infection.
| Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood infection markers Set 2 | All lab tests are optional, and ordered through the patient's physician. Infection markers in the blood may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. A higher titer indicates a higher level of infection.
| Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood infection markers Set 3 | All lab tests are optional, and ordered through the patient's physician. Infection markers in the blood may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate withALS/MND/PLS outcomes. The higher the marker, the higher the level of infection.
| Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood infection markers Set 4 | All lab tests are optional, and ordered through the patient's physician. Infection markers in the blood may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. A higher C4A can indicate a higher level of infection, inflammation or autoimmune conditions. a. C4A (Complement 4A) (mg/dL) | Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in blood infection markers Set 5 | All lab tests are optional, and ordered through the patient's physician. Infection markers in the blood may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. A higher LPS can indicate bacteria from the gut entering the bloodstream because of increased intestinal permeability. a. LPS Lipopolysaccharides by Endotoxin Activity Assay (EU - Endotoxin Units) | Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in urine toxin markers Set 1 | All lab tests are optional, and ordered through the patient's physician. Increased levels of urine toxins may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
| Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in urine toxin markers Set 2 | All lab tests are optional, and ordered through the patient's physician. Increased levels of urine toxins may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
| Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| Change in NfL (Neurofilament Light chain) | All lab tests are optional, and ordered through the patient's physician and recorded. NfL (lNeurofilament Light chain) can be used to assess neuronal damage with ALS/MND/PLS. A higher level of NfL often indicates a higher level of neuronal damage. The investigators will analyze how changes in NfL correlate with ALS/MND/PLS outcomes.
| Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline. |
| 32331298 | Background | Filippini T, Tesauro M, Fiore M, Malagoli C, Consonni M, Violi F, Iacuzio L, Arcolin E, Oliveri Conti G, Cristaldi A, Zuccarello P, Zucchi E, Mazzini L, Pisano F, Gagliardi I, Patti F, Mandrioli J, Ferrante M, Vinceti M. Environmental and Occupational Risk Factors of Amyotrophic Lateral Sclerosis: A Population-Based Case-Control Study. Int J Environ Res Public Health. 2020 Apr 22;17(8):2882. doi: 10.3390/ijerph17082882. |
| 25892962 | Background | Alonso R, Pisa D, Marina AI, Morato E, Rabano A, Rodal I, Carrasco L. Evidence for fungal infection in cerebrospinal fluid and brain tissue from patients with amyotrophic lateral sclerosis. Int J Biol Sci. 2015 Apr 2;11(5):546-58. doi: 10.7150/ijbs.11084. eCollection 2015. |
| 32335431 | Background | Fiore M, Parisio R, Filippini T, Mantione V, Platania A, Odone A, Signorelli C, Pietrini V, Mandrioli J, Teggi S, Costanzini S, Antonio C, Zuccarello P, Oliveri Conti G, Nicoletti A, Zappia M, Vinceti M, Ferrante M. Living near waterbodies as a proxy of cyanobacteria exposure and risk of amyotrophic lateral sclerosis: a population based case-control study. Environ Res. 2020 Jul;186:109530. doi: 10.1016/j.envres.2020.109530. Epub 2020 Apr 15. |
| 37219417 | Background | Sales de Campos P, Olsen WL, Wymer JP, Smith BK. Respiratory therapies for Amyotrophic Lateral Sclerosis: A state of the art review. Chron Respir Dis. 2023 Jan-Dec;20:14799731231175915. doi: 10.1177/14799731231175915. |
| 35918363 | Background | Li JY, Sun XH, Cai ZY, Shen DC, Yang XZ, Liu MS, Cui LY. Correlation of weight and body composition with disease progression rate in patients with amyotrophic lateral sclerosis. Sci Rep. 2022 Aug 2;12(1):13292. doi: 10.1038/s41598-022-16229-9. |
| 31487846 | Background | Bond L, Ganguly P, Khamankar N, Mallet N, Bowen G, Green B, Mitchell CS. A Comprehensive Examination of Percutaneous Endoscopic Gastrostomy and Its Association with Amyotrophic Lateral Sclerosis Patient Outcomes. Brain Sci. 2019 Sep 4;9(9):223. doi: 10.3390/brainsci9090223. |
| 19922121 | Background | Floeter MK, Mills R. Progression in primary lateral sclerosis: a prospective analysis. Amyotroph Lateral Scler. 2009 Oct-Dec;10(5-6):339-46. doi: 10.3109/17482960903171136. |
| Background | Syrow L, Calderwood D, Newton C; An Integrative Medicine approach may slow disease in ALS patients compared to standard of care: A pilot observational study. Annals of Neurology Volume 96, Number S32, 149th Annual Meeting American Neurological Association pp. S278-279 (September 2024) https://onlinelibrary.wiley.com/doi/10.1002/ana.27051 |
| 29607695 | Background | Harrison D, Mehta P, van Es MA, Stommel E, Drory VE, Nefussy B, van den Berg LH, Crayle J, Bedlack R; Pooled Resource Open-Access ALS Clinical Trials Consortium. "ALS reversals": demographics, disease characteristics, treatments, and co-morbidities. Amyotroph Lateral Scler Frontotemporal Degener. 2018 Nov;19(7-8):495-499. doi: 10.1080/21678421.2018.1457059. Epub 2018 Apr 2. |
| 35775279 | Background | Crayle J, Lutz M, Raymond J, Mehta P, Bedlack R. Study of "ALS reversals": LifeTime environmental exposures (StARLiTE). Amyotroph Lateral Scler Frontotemporal Degener. 2023 Feb;24(1-2):54-62. doi: 10.1080/21678421.2022.2090846. Epub 2022 Jul 1. |
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D016472 | Motor Neuron Disease |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008903 | Minerals |
| D019122 | Meditation |
| D011613 | Psychotherapy |
| D004032 | Diet |
| D015444 | Exercise |
| D026741 | Physical Therapy Modalities |
| D009788 | Occupational Therapy |
| D013070 | Speech Therapy |
| D029002 | Steam Bath |
| D008405 | Massage |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |
| D001521 | Behavior Therapy |
| D004191 | Behavioral Disciplines and Activities |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D012049 | Rehabilitation of Speech and Language Disorders |
| D001452 | Balneology |
| D006979 | Hyperthermia, Induced |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D032763 | Behavior Control |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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