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| Name | Class |
|---|---|
| Klinik Lengg, Zurich | OTHER |
| Reha Rheinfelden | OTHER |
| Klinik Valens | OTHER |
| Rehaklinik Zihlschlacht AG |
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The objective of the current study is to develop and investigate training concepts involving rehabilitation technology, which aim at exploiting the potential for regaining the ability to perform skilled movements by maximizing training intensity and keeping the motivation of patients high.
The evaluation focuses on feasibility and cost-benefit analyses
This feasibility project aims to establish an efficient setting for intensive rehabilitation with new technology in four trailblazer clinics. This will enable them to provide intensive therapy to the patients in accordance with the study protocol. If this setting is integrated into the clinical routine, the investigators will be able to collect data to get some first insight into economic and functional data required to calculate changes in socioeconomic costs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Technology arm | Experimental | 4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation technology | Other |
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Scheduled and Performed Trainings | Adherence was operationalized by correlating planned trainings with trainings which were carried out by the participants. Due to the small sample size Spearman's rank correlation was used. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measurement (FIM) Generic Functional Performance | observer based measurement of the subject performing basic functional tests, e.g. sitting-up from lying position, stand-up from sitting, walking, stair-climbing etc. Observer rate on a scale from 1 to 7 (1= totally dependent on aid, 7= totally independent) for each activity 18 items, that would led to a score from 18 (totally dependent) to 126 (totally independent) |
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Inclusion Criteria:
Exclusion Criteria:
Patients with any signs and symptoms showing that the participant is unwilling to participate in the study will result in the patient being excluded from participation Any medical condition preventing participation such as Severe respiratory disease Severe OR unstable cardio-circulatory conditions Orthopaedic conditions, especially in extremities targeted for rehabilitation such as
Specific absolute contraindication for the training with any of the respective devices:
Device specific contraindications will be respected and will lead to the exclusion of the device for that patient.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reha Rheinfelden | Rheinfelden | 4310 | Switzerland | |||
| Kliniken Valens |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24756870 | Background | Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J, Pomeroy VM, Langhorne P. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD001920. doi: 10.1002/14651858.CD001920.pub3. | |
| 24505342 | Background | Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Technology Arm | 4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting. Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Technology Arm | 4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting. Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Correlation Between Scheduled and Performed Trainings | Adherence was operationalized by correlating planned trainings with trainings which were carried out by the participants. Due to the small sample size Spearman's rank correlation was used. | Posted | Number | 95% Confidence Interval | correlation coefficient | 4 weeks |
|
over the 4 weeks rehabilitation period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Technology Arm | 4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting. Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Markus Wirz | Zurich University of applied sciences | +41 58 934 | 6321 | markus.wirz@zhaw.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2018 | Aug 15, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C108128 | frovatriptan |
Not provided
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Not provided
| OTHER |
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|
|
| Baseline and 4 weeks |
| Stroke Impact Scale (SIS) Recovery | Questionnaire to be completed by the patient, regarding different parts in daily life: 1. physical problems: 4 items, 2. memory and thinking: 7 items, 3. mood and emotional control: 9 items, 4. communication and understanding: 7 items, 5.daily activities: 10 items, 6. mobility at home and community: 9 items, 7. hand function: 5 items, 8. participation in life: 8 items. each item should be rated on on 5-point Lickert scale with 1= extremely difficult OR can't do at all OR no strength at all OR all the time AND 5 means: a lot of strength OR not difficult at all OR none of the time OR Question 9 regarding "recovery from stroke" rated on a scale from 0 - 100 (0= no recovery, 100= full recovery) | Baseline and 4 weeks |
| Box and Block Test | Measures broader motoric function of the arm and hand as a performance test. Subjects are required to grab and sort wooden blocks from one side of a small dividing wall set up on a table in front of the sitting subject to another side. The unit of the measure is the amount of blocks transferred within 60 seconds. | Baseline and 4 weeks |
| Functional Ambulation Categories (FAC) | Observer based measurement to rate the ability to walk independently. Rated from 0 to 6 (0= not able to walk independently, 6= can walk independently in every situation) | Baseline and 4 weeks |
| 10m Walk Test= TMT Comfortable | time needed to walk 10 m with Comfortable walking speed | Baseline and 4 weeks |
| Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA) | The Walking Index consists of the 5 following items: Walking indoors Walking outdoors, over rough ground, ramps, and curbs Walking outdoors several blocks Stairs Age and sex appropriate walking distance in meters for 2 minutes scored on a 7-point scale (Stage 1 through 7, most impairment through to no impairment, respectively) score from 5 to 35 points, the more points the better | Baseline and 4 weeks |
| Berg Balance Scale (BBS) | Observer based measurement of walking, standing and balance with 14 items/task to perform by the subject and rated each on scale from 0 to 4 (0= not able to do without help, 4 = can do safely and independently) score between 0 to 56, the more the better | Baseline and 4 weeks |
| Valens |
| 7317 |
| Switzerland |
| Rehakliniken Zihlschlacht | Zihlschlacht | 8588 | Switzerland |
| Klinik Lengg AG | Zurich | 8008 | Switzerland |
| 9238725 | Background | Langhorne P, Wagenaar R, Partridge C. Physiotherapy after stroke: more is better? Physiother Res Int. 1996;1(2):75-88. doi: 10.1002/pri.6120010204. |
| 26338433 | Background | Hornby TG, Holleran CL, Hennessy PW, Leddy AL, Connolly M, Camardo J, Woodward J, Mahtani G, Lovell L, Roth EJ. Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2016 Jun;30(5):440-50. doi: 10.1177/1545968315604396. Epub 2015 Sep 3. |
| 26069298 | Background | Knecht S, Rossmuller J, Unrath M, Stephan KM, Berger K, Studer B. Old benefit as much as young patients with stroke from high-intensity neurorehabilitation: cohort analysis. J Neurol Neurosurg Psychiatry. 2016 May;87(5):526-30. doi: 10.1136/jnnp-2015-310344. Epub 2015 Jun 11. |
| 10421300 | Background | Kwakkel G, Wagenaar RC, Twisk JW, Lankhorst GJ, Koetsier JC. Intensity of leg and arm training after primary middle-cerebral-artery stroke: a randomised trial. Lancet. 1999 Jul 17;354(9174):191-6. doi: 10.1016/S0140-6736(98)09477-X. |
| 15001789 | Background | Feys H, De Weerdt W, Verbeke G, Steck GC, Capiau C, Kiekens C, Dejaeger E, Van Hoydonck G, Vermeersch G, Cras P. Early and repetitive stimulation of the arm can substantially improve the long-term outcome after stroke: a 5-year follow-up study of a randomized trial. Stroke. 2004 Apr;35(4):924-9. doi: 10.1161/01.STR.0000121645.44752.f7. Epub 2004 Mar 4. |
| 15759214 | Background | Jette DU, Warren RL, Wirtalla C. The relation between therapy intensity and outcomes of rehabilitation in skilled nursing facilities. Arch Phys Med Rehabil. 2005 Mar;86(3):373-9. doi: 10.1016/j.apmr.2004.10.018. |
| 24867924 | Background | Lohse KR, Lang CE, Boyd LA. Is more better? Using metadata to explore dose-response relationships in stroke rehabilitation. Stroke. 2014 Jul;45(7):2053-8. doi: 10.1161/STROKEAHA.114.004695. Epub 2014 May 27. |
| 20424192 | Background | Birkenmeier RL, Prager EM, Lang CE. Translating animal doses of task-specific training to people with chronic stroke in 1-hour therapy sessions: a proof-of-concept study. Neurorehabil Neural Repair. 2010 Sep;24(7):620-35. doi: 10.1177/1545968310361957. Epub 2010 Apr 27. |
| 15472114 | Background | Kwakkel G, van Peppen R, Wagenaar RC, Wood Dauphinee S, Richards C, Ashburn A, Miller K, Lincoln N, Partridge C, Wellwood I, Langhorne P. Effects of augmented exercise therapy time after stroke: a meta-analysis. Stroke. 2004 Nov;35(11):2529-39. doi: 10.1161/01.STR.0000143153.76460.7d. Epub 2004 Oct 7. |
| 16110427 | Background | Teasell R, Bitensky J, Salter K, Bayona NA. The role of timing and intensity of rehabilitation therapies. Top Stroke Rehabil. 2005 Summer;12(3):46-57. doi: 10.1310/ETDP-6DR4-D617-VMVF. |
| 26089042 | Background | Andrews AW, Li D, Freburger JK. Association of Rehabilitation Intensity for Stroke and Risk of Hospital Readmission. Phys Ther. 2015 Dec;95(12):1660-7. doi: 10.2522/ptj.20140610. Epub 2015 Jun 18. |
| 22466792 | Background | Krakauer JW, Carmichael ST, Corbett D, Wittenberg GF. Getting neurorehabilitation right: what can be learned from animal models? Neurorehabil Neural Repair. 2012 Oct;26(8):923-31. doi: 10.1177/1545968312440745. Epub 2012 Mar 30. |
| 16081860 | Background | De Wit L, Putman K, Dejaeger E, Baert I, Berman P, Bogaerts K, Brinkmann N, Connell L, Feys H, Jenni W, Kaske C, Lesaffre E, Leys M, Lincoln N, Louckx F, Schuback B, Schupp W, Smith B, De Weerdt W. Use of time by stroke patients: a comparison of four European rehabilitation centers. Stroke. 2005 Sep;36(9):1977-83. doi: 10.1161/01.STR.0000177871.59003.e3. Epub 2005 Aug 4. |
| 17540968 | Background | De Wit L, Putman K, Schuback B, Komarek A, Angst F, Baert I, Berman P, Bogaerts K, Brinkmann N, Connell L, Dejaeger E, Feys H, Jenni W, Kaske C, Lesaffre E, Leys M, Lincoln N, Louckx F, Schupp W, Smith B, De Weerdt W. Motor and functional recovery after stroke: a comparison of 4 European rehabilitation centers. Stroke. 2007 Jul;38(7):2101-7. doi: 10.1161/STROKEAHA.107.482869. Epub 2007 May 31. |
| 25568073 | Background | Hayward KS, Brauer SG. Dose of arm activity training during acute and subacute rehabilitation post stroke: a systematic review of the literature. Clin Rehabil. 2015 Dec;29(12):1234-43. doi: 10.1177/0269215514565395. Epub 2015 Jan 7. |
| 19801058 | Background | Lang CE, Macdonald JR, Reisman DS, Boyd L, Jacobson Kimberley T, Schindler-Ivens SM, Hornby TG, Ross SA, Scheets PL. Observation of amounts of movement practice provided during stroke rehabilitation. Arch Phys Med Rehabil. 2009 Oct;90(10):1692-8. doi: 10.1016/j.apmr.2009.04.005. |
| 17558358 | Background | Lang CE, Wagner JM, Edwards DF, Dromerick AW. Upper extremity use in people with hemiparesis in the first few weeks after stroke. J Neurol Phys Ther. 2007 Jun;31(2):56-63. doi: 10.1097/NPT.0b013e31806748bd. |
| 8466415 | Background | Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54. |
| 1178004 | Background | Gresham GE, Fitzpatrick TE, Wolf PA, McNamara PM, Kannel WB, Dawber TR. Residual disability in survivors of stroke--the Framingham study. N Engl J Med. 1975 Nov 6;293(19):954-6. doi: 10.1056/NEJM197511062931903. |
| 26966382 | Background | Johnson BH, Bonafede MM, Watson C. Short- and longer-term health-care resource utilization and costs associated with acute ischemic stroke. Clinicoecon Outcomes Res. 2016 Feb 23;8:53-61. doi: 10.2147/CEOR.S95662. eCollection 2016. |
| 17143007 | Background | McGuire AJ, Raikou M, Whittle I, Christensen MC. Long-term mortality, morbidity and hospital care following intracerebral hemorrhage: an 11-year cohort study. Cerebrovasc Dis. 2007;23(2-3):221-8. doi: 10.1159/000097645. Epub 2006 Dec 1. |
| 8784113 | Background | Taylor TN, Davis PH, Torner JC, Holmes J, Meyer JW, Jacobson MF. Lifetime cost of stroke in the United States. Stroke. 1996 Sep;27(9):1459-66. doi: 10.1161/01.str.27.9.1459. |
| 27371489 | Background | Zhao Y, Condon J, Lawton P, He V, Cadilhac DA. Lifetime direct costs of stroke for indigenous patients adjusted for comorbidities. Neurology. 2016 Aug 2;87(5):458-65. doi: 10.1212/WNL.0000000000002908. Epub 2016 Jul 1. |
| 25420902 | Background | Duret C, Hutin E, Lehenaff L, Gracies JM. Do all sub acute stroke patients benefit from robot-assisted therapy? A retrospective study. Restor Neurol Neurosci. 2015;33(1):57-65. doi: 10.3233/RNN-140418. |
| 20400552 | Background | Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16. |
| 22446153 | Background | Spiess MR, Jaramillo JP, Behrman AL, Teraoka JK, Patten C. Unexpected recovery after robotic locomotor training at physiologic stepping speed: a single-case design. Arch Phys Med Rehabil. 2012 Aug;93(8):1476-84. doi: 10.1016/j.apmr.2012.02.030. Epub 2012 Mar 23. |
| 24396811 | Background | Chang WH, Kim YH. Robot-assisted Therapy in Stroke Rehabilitation. J Stroke. 2013 Sep;15(3):174-81. doi: 10.5853/jos.2013.15.3.174. Epub 2013 Sep 27. |
| 24479445 | Background | Masiero S, Poli P, Rosati G, Zanotto D, Iosa M, Paolucci S, Morone G. The value of robotic systems in stroke rehabilitation. Expert Rev Med Devices. 2014 Mar;11(2):187-98. doi: 10.1586/17434440.2014.882766. Epub 2014 Jan 30. |
| 21674390 | Background | Tefertiller C, Pharo B, Evans N, Winchester P. Efficacy of rehabilitation robotics for walking training in neurological disorders: a review. J Rehabil Res Dev. 2011;48(4):387-416. doi: 10.1682/jrrd.2010.04.0055. |
| 20412721 | Background | Waldner A, Tomelleri C, Hesse S. Transfer of scientific concepts to clinical practice: recent robot-assisted training studies. Funct Neurol. 2009 Oct-Dec;24(4):173-7. |
| 25600057 | Background | Babaiasl M, Mahdioun SH, Jaryani P, Yazdani M. A review of technological and clinical aspects of robot-aided rehabilitation of upper-extremity after stroke. Disabil Rehabil Assist Technol. 2016;11(4):263-80. doi: 10.3109/17483107.2014.1002539. Epub 2015 Jan 20. |
| 28626059 | Background | Mehrholz J, Thomas S, Werner C, Kugler J, Pohl M, Elsner B. Electromechanical-Assisted Training for Walking After Stroke: A Major Update of the Evidence. Stroke. 2017 Jun 16:STROKEAHA.117.018018. doi: 10.1161/STROKEAHA.117.018018. Online ahead of print. No abstract available. |
| 35791026 | Background | Schuster-Amft C, Kool J, Moller JC, Schweinfurther R, Ernst MJ, Reicherzer L, Ziller C, Schwab ME, Wieser S, Wirz M; SRTI study group. Feasibility and cost description of highly intensive rehabilitation involving new technologies in patients with post-acute stroke-a trial of the Swiss RehabTech Initiative. Pilot Feasibility Stud. 2022 Jul 5;8(1):139. doi: 10.1186/s40814-022-01086-0. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Paretic side | Left /Right side | Count of Participants | Participants |
|
| Montreal Cognitive assessment (MoCA) | 0-30 points on scale, more points meaning better cognitive function | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | Functional Independence Measurement (FIM) Generic Functional Performance | observer based measurement of the subject performing basic functional tests, e.g. sitting-up from lying position, stand-up from sitting, walking, stair-climbing etc. Observer rate on a scale from 1 to 7 (1= totally dependent on aid, 7= totally independent) for each activity 18 items, that would led to a score from 18 (totally dependent) to 126 (totally independent) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 weeks |
|
|
|
| Secondary | Stroke Impact Scale (SIS) Recovery | Questionnaire to be completed by the patient, regarding different parts in daily life: 1. physical problems: 4 items, 2. memory and thinking: 7 items, 3. mood and emotional control: 9 items, 4. communication and understanding: 7 items, 5.daily activities: 10 items, 6. mobility at home and community: 9 items, 7. hand function: 5 items, 8. participation in life: 8 items. each item should be rated on on 5-point Lickert scale with 1= extremely difficult OR can't do at all OR no strength at all OR all the time AND 5 means: a lot of strength OR not difficult at all OR none of the time OR Question 9 regarding "recovery from stroke" rated on a scale from 0 - 100 (0= no recovery, 100= full recovery) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 weeks |
|
|
|
| Secondary | Box and Block Test | Measures broader motoric function of the arm and hand as a performance test. Subjects are required to grab and sort wooden blocks from one side of a small dividing wall set up on a table in front of the sitting subject to another side. The unit of the measure is the amount of blocks transferred within 60 seconds. | Posted | Mean | Standard Deviation | blocks/60 sec | Baseline and 4 weeks |
|
|
|
| Secondary | Functional Ambulation Categories (FAC) | Observer based measurement to rate the ability to walk independently. Rated from 0 to 6 (0= not able to walk independently, 6= can walk independently in every situation) | Posted | Median | Full Range | units on a scale | Baseline and 4 weeks |
|
|
|
| Secondary | 10m Walk Test= TMT Comfortable | time needed to walk 10 m with Comfortable walking speed | Posted | Mean | Standard Deviation | seconds | Baseline and 4 weeks |
|
|
|
| Secondary | Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA) | The Walking Index consists of the 5 following items: Walking indoors Walking outdoors, over rough ground, ramps, and curbs Walking outdoors several blocks Stairs Age and sex appropriate walking distance in meters for 2 minutes scored on a 7-point scale (Stage 1 through 7, most impairment through to no impairment, respectively) score from 5 to 35 points, the more points the better | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 weeks |
|
|
|
| Secondary | Berg Balance Scale (BBS) | Observer based measurement of walking, standing and balance with 14 items/task to perform by the subject and rated each on scale from 0 to 4 (0= not able to do without help, 4 = can do safely and independently) score between 0 to 56, the more the better | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 weeks |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |