Constraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment

Официальное название

Constraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment and Deficits in Desired Occupational Performance: A Pilot Study

Обзор

Constraint-Induced Therapy (CI Therapy) is a behavioral approach to neurorehabilitation and consists of multi-components that have been applied in a systematic method to improve the use of the limb or function addressed in the intensive treatment. CI Therapy for the more-affected upper extremity (UE) post-stroke is administered in daily treatment sessions over consecutive weekdays. Sessions include motor training with repeated, timed trials using a technique called shaping, a set of behavioral strategies known as the Transfer Package (TP) to improve the use of the more-affected hand in the life situation, and strategies to remind participants to use the more-affected UE including restraint. Robust improvements in the amount and qualify of use have been realized with stroke participants from mild-to-severe UE impairment.

Подробное описание

Previous CI therapy studies have explored treatment for participants with varied levels of motor impairment from mild-to-severe that have limited use of the more-affected arm and hand in everyday activities as measured by the Motor Activity Log (MAL). The Motor Activity Log (MAL) is a standardized test used in CI therapy studies to measure the Amount of Use and the Quality of Use of the more-affected UE in the life situation. Individuals that exceed maximal criteria with a mean MAL score higher than 2.5 are typically excluded from CI therapy studies since they potentially would hit a ceiling effect on the MAL and would not be able to show a meaningful treatment change. Similarly, in a clinical setting, these individuals are often discharged from outpatient therapy as having reached the maximum benefit of traditional therapy since each can typically perform basic skills with the more-affected UE despite the disparity of continued difficulty with performing high-level motor tasks and persistent sensory deficits. However, these patients often voice strong motivation to gain more recovery and return to performing activities of daily living (ADL) and instrumental activities of daily living (IADL)that require complex motor skills (i.e.; keyboarding, texting, utensil or tool use, musical instrument use, etc). We hypothesize that participants with mild UE movement deficits will benefit from CI therapy with focused intervention to address skills and performance of high-level tasks and outcome measures that are selected for this level of patient. We further question if adding sensory components to the CI therapy strategies will improve the participant's sensation for the more-affected UE and aid in the more-affected UE use in everyday tasks but particularly in challenging motor tasks.

Вмешательства

• Поведенческое Grade 1 CI Therapy +Sensory Components
  All participants will receive Grade 1 CI Therapy + Sensory Components over a two-week period of time. The treatment intervention will include all CI Therapy treatment strategies including: 1) supervised motor training in the form of shaping with repeated trials and task practice for 1.5 hours per day for 5 weekdays for 2 weeks 2) a behavioral Transfer Package (TP) will be employed to aid carry-over of skills gained by the participant in the laboratory to the life situation 3) each participant wi

Первичные конечные точки

• 45-Item Motor Activity Log (MAL) [Срок оценки: At post treatment after 2 weeks of intervention]
• 45-Item Motor Activity Log (MAL) [Срок оценки: At 3 months after the end of the treatment]
• Wolf Motor Function Test (WMFT) [Срок оценки: At post treatment after the 2 weeks of intervention]
• Canadian Occupational Performance Measure (COPM) [Срок оценки: At post-treatment after the 2 weeks of intervention]
• Canadian Occupational Performance Measure (COPM) [Срок оценки: At follow-up at 3 months following the end of treatment.]

Вторичные конечные точки (7)

• Beck Depression Inventory (BDI) [Срок оценки: At post- treatment following the 2 weeks of treatment]
• Beck Depression Inventory (BDI) [Срок оценки: At 3 month follow up from the end of the 2 weeks of treatment.]
• Stroke Impact Scale (SIS) [Срок оценки: At post-treatment following the 2 weeks of treatment]
• Stroke Impact Scale (SIS) [Срок оценки: At 3 months following the end of the 2 weeks of treatment.]
• 9 Hole Peg Test (9HPT) [Срок оценки: At post-treatment after the 2 weeks of intervention]
• Revised Nottingham Sensory Assessment (rNSA) [Срок оценки: At post-treatment after the 2 weeks of intervention]
• Semmes-Weinstein Monofilament Test (SWMT) [Срок оценки: At post-treatment after the 2 weeks of intervention]

Критерии участия

Критерии включения

• At least 6 months post stroke
• The ability to demonstrate the minimum UE active movement criteria of 20 degrees of wrist extension from a fully flexed position, 10 degrees of thumb extension or abduction, and 10 degrees of extension of all finger joints.
• Mean score of >2.5 on the Motor Activity Log indicating the participant's use of the more-affected UE.

Критерии исключения

• Score< 24 on the Mini Mental State Exam
• Inability to answer the MAL questions and/or provide informed consent
• The inability to come in to the laboratory setting for treatment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Alabama at Birmingham — Birmingham

Публикации

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• 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. PMID 8466415
• Morris DM, Taub E, Mark VW. Constraint-induced movement therapy: characterizing the intervention protocol. Eura Medicophys. 2006 Sep;42(3):257-68. PMID 17039224
• Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006 Sep;42(3):241-56. PMID 17039223
• Uswatte G, Taub E, Morris D, Light K, Thompson PA. The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006 Oct 10;67(7):1189-94. doi: 10.1212/01.wnl.0000238164.90657.c2. PMID 17030751
• Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183. PMID 11387578
• Toomey M, Nicholson D, Carswell A. The clinical utility of the Canadian Occupational Performance Measure. Can J Occup Ther. 1995 Dec;62(5):242-9. doi: 10.1177/000841749506200503. PMID 10152880
• Duncan PW, Wallace D, Lai SM, Johnson D, Embretson S, Laster LJ. The stroke impact scale version 2.0. Evaluation of reliability, validity, and sensitivity to change. Stroke. 1999 Oct;30(10):2131-40. doi: 10.1161/01.str.30.10.2131. PMID 10512918

Идентификаторы

NCT: NCT05492513 · IRB-300008653 · UAB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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