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To investigate the effect of "High Tone Power Therapy" (HTPT) on fatigue and functional outcomes in multiple sclerosis (MS). BACKGROUND: Fatigue and functional limitations considered serious disorders in patients with multiple sclerosis that lead to impairment of the physical activities and disruption of the quality of life (QOL).
HYPOTHESES:
This study hypothesized that:
High Tone Power Therapy will have a significant beneficial effect on fatigue and functional outcomes in in multiple sclerosis
RESEARCH QUESTION:
Is there a beneficial effect of High Tone Power Therapy on fatigue and functional outcomes in multiple sclerosis?
Double blind randomized study including 40 patients with MS. The patients will be randomly allocated into 2 arms: active arm and placebo arm; in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program, and the placebo arm will receive the same physical exercise program with sham "high tone power therapy". Either program will be applied 3 times per week for 4 weeks.
The evaluation methods will be done using:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program |
|
| control group | Sham Comparator | the sham arm will receive the same physical exercise program with sham "high tone power therapy". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Tone Power Therapy | Device | High Tone Power Therapy (HiTop 191): (For group I). The high tone power therapy through using a device (HiTop 191; gbo Medizintechnik, Rimbach, Germany). The intensity of the electrical stimulation will be adjusted to a pleasant level that did not produce any pain or discomfort. |
| Measure | Description | Time Frame |
|---|---|---|
| Expanded Disability Status Scale (EDSS) | The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. The scale was developed by a neurologist called John Kurtzke in 1983 as an advance from his previous 10 step Disability Status Scale (DSS). The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems | 4 weeks |
| Functional Systems Score (FSS), | On a scale of 0 to 6, the functional system score (FSS) measures how well the major central nervous systems are working and assigns a score to the patient disability. This score uses also information about the gait and use of assistive devices. | 4 weeks |
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Inclusion Criteria:
- Both genders
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lama S Mahmoud | Cairo University | Study Director |
| Khalid T Turky, PHD | Ph.D., Assist. prof : Physical Therapy | Study Chair |
| Nevin M Shalaby, PHD | Professor of neurology Department of Neurology , Faculty of Medicine, Cairo University. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Al-Ainy MS clinic, Neurology department, Cairo University hospitals. | Al Jīzah | Select State | Egypt |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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active arm and placebo arm; in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program, and the placebo arm will receive the same physical exercise program with sham "high tone power therapy".
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|
| exercise program | Other | physical therapy conventional selected exercise program inform of functional activities of daily living |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |