The Effectiveness of Occupation-based Bilateral Arm Training on Motor Functions and Activity Participation Among Stroke Survivors During Inpatient Rehabilitation.

Официальное название

The Effectiveness of Occupation-based Bilateral Arm Training on Motor Functions and Activity Participation Among Stroke Survivors During Inpatient Rehabilitation. A Randomized Control Trial

Обзор

People with stroke often experience limitations in motor functions and activity participation. Occupation-based bilateral upper limb training (OBBT) using occupations as meaningful daily activities, and as part of the therapy. The activities in OBBT are tailored to the patient's life with the goal of boosting motivation and engagement to enhance activity performance and participation. This study is a randomized control trial that aims to explore the effect of OBBT along with the conventional therapy in comparison with the conventional therapy alone on motor functions and activity participation among stroke survivors in inpatient rehabilitation setting. This study will be conducted in Qatar Rehabilitation Institute, Hamad Medical Corporation, Doha, Qatar. Participants will be allocated randomly to either the OBBT group or the conventional therapy group. Participants in the OBBT group will receive 30 minutes OBBT program in addition to conventional therapy (90 minutes). Intervention sessions will be conducted 5 times per week over 6 weeks. The participants in the conventional therapy group will receive only the conventional therapy (90 minute). All participants will be assessed using the outcome measure immediately the day after completing the last intervention session at 4th week and 6th week.

Вмешательства

• Другое Occupation-Based Bilateral Upper Limb Training (OBBT)
  Intervention sessions for experimental group will be conducted 5 times per week over 6 weeks. OBBT will be used to engage both upper limbs simultaneously in simulate real-life functional tasks which tailored to individual needs, focusing on improving the patient's ability to perform daily activities such as dressing, washing, and cooking. The training will emphasize occupation-specific repetitive practice for at least two selected occupations and encouraged active participation of both hands dur
• Другое Conventional therapy group
  Conventional therapy includes passive and active range of motion exercises, strengthening exercises, basic functional activities and mobility training, and activities designed to improve muscle tone and mobility in the affected upper limb among stroke survivors. The conventional therapy sessions will be delivered 5 times per week for 90 minutes over 6 weeks. Therapy sessions will be individualized to the participant's needs and will be provided by senior occupational therapists.

Первичные конечные точки

• Fugl-Meyer Assessment (FMA) [Срок оценки: At baseline, immediately post 4th weeks, and 6th week of the intervention.]

Вторичные конечные точки (4)

• Action Research Arm Test (ARAT) [Срок оценки: It will be conducted at baseline, immediately post 4th weeks, and 6th week of the intervention.]
• Functional independence measure (FIM) [Срок оценки: At baseline, immediately post 4th weeks, and 6th week of the intervention.]
• Stroke Impact Scale (SIS) [Срок оценки: At baseline, immediately post 4th weeks, and 6th week of the intervention.]
• Canadian Occupational Performance Measure (COPM) [Срок оценки: At baseline, immediately post 4th weeks, and 6th week of the intervention.]

Критерии участия

Критерии включения

• Diagnosed with first ischemic or hemorrhagic stroke by medical physician
• Stroke onset ≤ 6 months
• Both males and females with age 18-65 years
• Cognitive functions within normal and mild deficit (MMSE ≥ 22)
• With arm and hand upper extremity Brunnstrom stage of >3
• Free of any other neurological diseases.

Критерии исключения

• participants with previous stroke
• musculoskeletal disease or sever pain affecting the upper extremities
• participant who have taken part in another rehabilitative research
• sever visual neglect or visual field deficit.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Катар · 1 центр

• Hamad Medical Corporation\ Qatar Rehabilitation Institute — Doha

Публикации

• Dembele J, Triccas LT, Amanzonwe LER, Kossi O, Spooren A. Bilateral versus unilateral upper limb training in (sub)acute stroke: A systematic and meta-analysis. S Afr J Physiother. 2024 Jan 23;80(1):1985. doi: 10.4102/sajp.v80i1.1985. eCollection 2024. PMID 38322652
• Kim SH, Park JH. The Effect of Occupation-Based Bilateral Upper Extremity Training in a Medical Setting for Stroke Patients: A Single-Blinded, Pilot Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2019 Dec;28(12):104335. doi: 10.1016/j.jstrokecerebrovasdis.2019.104335. Epub 2019 Sep 30. PMID 31582271
• Meng G, Meng X, Tan Y, Yu J, Jin A, Zhao Y, Liu X. Short-term Efficacy of Hand-Arm Bimanual Intensive Training on Upper Arm Function in Acute Stroke Patients: A Randomized Controlled Trial. Front Neurol. 2018 Jan 19;8:726. doi: 10.3389/fneur.2017.00726. eCollection 2017. PMID 29403422
• Renner CIE, Brendel C, Hummelsheim H. Bilateral Arm Training vs Unilateral Arm Training for Severely Affected Patients With Stroke: Exploratory Single-Blinded Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Jul;101(7):1120-1130. doi: 10.1016/j.apmr.2020.02.007. Epub 2020 Mar 4. PMID 32145277
• Stoykov ME, Lewis GN, Corcos DM. Comparison of bilateral and unilateral training for upper extremity hemiparesis in stroke. Neurorehabil Neural Repair. 2009 Nov;23(9):945-53. doi: 10.1177/1545968309338190. Epub 2009 Jun 16. PMID 19531608
• Summers JJ, Kagerer FA, Garry MI, Hiraga CY, Loftus A, Cauraugh JH. Bilateral and unilateral movement training on upper limb function in chronic stroke patients: A TMS study. J Neurol Sci. 2007 Jan 15;252(1):76-82. doi: 10.1016/j.jns.2006.10.011. Epub 2006 Nov 28. PMID 17134723

Идентификаторы

NCT: NCT07164612 · MRC-01-25-298

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗