COgnitive-somatoSensory-MOtor Training to Improve Arm and Hand Function After Stroke (iCOSMO)

Официальное название

Comparing the Effect of a Graded Repetitive Arm Supplementary Home-based Exercise Programme With COgnitive-somatoSensory-MOtor Training to Improve Arm and Hand Function After Stroke (iCOSMO)

Обзор

The iCOSMO study investigates the feasibility and beneficial effects of an intervention combining sensation, motor and cognition to improve arm and hand function after chronic stroke.

Подробное описание

The iCOSMO is a two-arm randomized controlled trial study evaluating the feasibility and efficacy of combined somatosensory-motor intervention using a cognitive approach to improve upper limb recovery in people with chronic stroke. Forty participants will be recruited (20 in experimental group and 20 in the control group). iCOSMO will include active touch and movement exploratory procedures during goal-oriented tasks as well as robotic training using the Kinarm Exoskeleton device. The experimental group will receive a total of 36 hours of treatment (6 weeks). The control group will receive a matched dose of a home-based motor exercise programme. The outcome measures will include measures of feasibility such as the recruitment and adherence rates and standardised clinical and robotic assessments. The participants will be tested at the start and end of the baseline phase, at post-intervention and at 1-month follow-up.

Вмешательства

• Другое Home Graded Repetitive Arm Supplementary Program (GRASP)
  The home-based exercise programme will be based on the Home Graded Repetitive Arm Supplementary Program focusing on stretching, arm strengthening, hand strengthening, coordination and hand skills. The Home Graded Repetitive Arm Supplementary Program will be delivered 2 hours/session, 3 times/week, for 6 weeks.
• Другое integrated Somatosensory-MOtor training using a COgnitive approach(iCOSMO)
  The first training approach of iCOSMO will focus on integrated somatosensory-motor variables during reaching and object manipulation (60 minutes). The second training approach will focus on proprioceptive, motor and cognitive tasks using the Kinarm robotic exoskeleton (60 minutes). iCOSMO will be delivered 3 times per week (2 hours per session) for 6 weeks (Total: 36 hours of treatment).

Первичные конечные точки

• Fidelity [Срок оценки: Through study completion, an average of 6 weeks]
• Kinarm standard tasks- the Reverse Visually Guided Reaching [Срок оценки: Baseline, immediately after intervention,1-month]
• Kinarm standard tasks- the Trail Making A&B [Срок оценки: Baseline, immediately after intervention,1-month]
• Kinarm standard tasks- the Object Hit and Avoid [Срок оценки: Baseline, immediately after intervention,1-month]
• Kinarm standard tasks- the Spatial Span Task [Срок оценки: Baseline, immediately after intervention,1-month]
• Kinarm standard tasks- the Paired Associates Learning [Срок оценки: Baseline, immediately after intervention,1-month]
• Kinarm standard tasks- the Visually Guided Reaching [Срок оценки: Baseline, immediately after intervention,1-month]
• Kinarm standard tasks- the Object Hit [Срок оценки: Baseline, immediately after intervention,1-month]
• Kinarm standard tasks- the Ball-on-Bar [Срок оценки: Baseline, immediately after intervention,1-month]
• Kinarm standard tasks- the Arm Posture Perturbation [Срок оценки: Baseline, immediately after intervention,1-month]

Вторичные конечные точки (2)

• Stanford Fatigue Visual Analogue Scale (SFVAS) [Срок оценки: Through study completion, an average of 6 weeks]
• Pain visual analogue scale (PVAS) [Срок оценки: Through study completion, an average of 6 weeks]

Критерии участия

Критерии включения

• Clinical diagnosis of stroke
• Must be more than 6 months post-stroke
• Must be above 18 years old
• Must have some motor and/or somatosensory deficits in the upper limbs

Критерии исключения

• A prior history of central nervous system dysfunction other than stroke
• Upper limb deficits resulting from non-stroke pathology
• Inability to cooperate, follow instructions or provide consent

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Toronto Rehabilitation Institute — Toronto

Публикации

• Gopaul U, van Vliet P, Callister R, Nilsson M, Carey L. COMbined Physical and somatoSEnsory training after stroke: Development and description of a novel intervention to improve upper limb function. Physiother Res Int. 2019 Jan;24(1):e1748. doi: 10.1002/pri.1748. Epub 2018 Sep 19. PMID 30230136
• 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. PMID 20424192
• Ritter PL, Gonzalez VM, Laurent DD, Lorig KR. Measurement of pain using the visual numeric scale. J Rheumatol. 2006 Mar;33(3):574-80. PMID 16511926
• Bourke TC, Lowrey CR, Dukelow SP, Bagg SD, Norman KE, Scott SH. A robot-based behavioural task to quantify impairments in rapid motor decisions and actions after stroke. J Neuroeng Rehabil. 2016 Oct 10;13(1):91. doi: 10.1186/s12984-016-0201-2. PMID 27724945
• Duncan PW, Propst M, Nelson SG. Reliability of the Fugl-Meyer assessment of sensorimotor recovery following cerebrovascular accident. Phys Ther. 1983 Oct;63(10):1606-10. doi: 10.1093/ptj/63.10.1606. PMID 6622535
• Ekstrand E, Lexell J, Brogardh C. Grip strength is a representative measure of muscle weakness in the upper extremity after stroke. Top Stroke Rehabil. 2016 Dec;23(6):400-405. doi: 10.1080/10749357.2016.1168591. Epub 2016 May 4. PMID 27145212
• Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386. PMID 3160243

Идентификаторы

NCT: NCT06498011 · 22-5628

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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