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临床试验/NCT02887872
NCT02887872已完成不适用

Combining Electrical Stimulation and a Dynamic Hand Orthosis for Functional Recovery in Chronic Stroke

The University of Texas Medical Branch, Galveston2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2011年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Change from baseline performance of functional tasks to post-intervention performance of functional tasks

研究概览

简要总结

Objective: To explore the effectiveness of a combined neuromuscular electrical stimulation (ES) and dynamic hand orthosis (DHO) regimen used with a small group of persons with chronic stroke in improving ability to perform daily tasks. Method: Four participants with chronic stroke participated in the combined ES-DHO regimen using the affected upper extremity (UE) five times (5X) per week for 6 weeks. Outcome measures included grip strength, range of motion (ROM), and analysis of muscle activation/deactivation during release of grasp through electromyography (EMG). Ability to perform daily functional tasks was assessed using the Assessment of Motor and Process Skills (AMPS). Results: Preliminary results suggest that improvements in strength, ROM and grasp deactivation are possible with the combined ES-DHO regimen. Ability to perform daily functional tasks improved in all participants. Conclusion: Results should be interpreted cautiously due to the pilot nature of the study and small participant number. Further research in this area is warranted.

详细描述

The purpose of this pilot study was to explore the outcomes on performance of functional daily living tasks following a six-week combined regimen using ES and the SaeboFlex orthosis with repetitive task training (RTT) in four persons with chronic stroke. Functional outcomes were assessed before and after (pre-post design) a six-week combined treatment regimen using the DHO during RTT followed by a regimen of ES. Feasibility and logistics for translation of these preliminary results to a larger, more comprehensive controlled trial were explored. Participants donned the orthosis on the affected upper extremity with therapist assistance and performed the RTT grasp/release practice daily for 30 minutes, 5X/week for 6 weeks (30 sessions).Following completion of the grasp/release practice, ES to the finger extensor muscles was provided for 15 minutes. Goniometry to measure range of motion (ROM) at wrist and fingers, dynamometry to measure hand strength, electromyography (EMG) collection to measure muscle activation/deactivation, and AMPS testing to measure functional activity performance were performed before starting the intervention (baseline) and one day after the final training session. Gains in grip strength, 3rd metacarpophalangeal (MP) flexion, AMPS motor score, and improved deactivation of grasp were observed in all participants. Wrist extension, 3rd MP extension, AMPS process score, EMG root mean square (RMS) and time to release grasp improved in three of the four participants.These preliminary pilot results begin to suggest that gains can be made in impairment areas of strength, ROM, and the functional movement pattern of grasp release with a combined ES-DHO program in individuals with chronic stroke. Perhaps most importantly, the results may indicate that this type of training may translate to improvement in performance of daily living tasks. Completion of this work suggests that a larger trial is feasible and logistically able to be performed. The preliminary data are limited in that only four volunteers with chronic stroke were studied, so the small numbers involved restrict generalizations of effectiveness and comprehensive analysis of outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • (1) having one or more contraindicated conditions to receive electrical stimulation (implanted pacemaker/electronics, surgical hardware, tumors, cellulitis, open wounds, etc.)

研究组 & 干预措施

Pilot data

Experimental

Four participants with chronic stroke participated in a 45-minute combined electrical stimulation-dynamic hand orthosis regimen using the affected upper extremity (UE) 5X/week for 6 weeks.

干预措施: Electrical stimulation-dynamic hand orthosis (Other)

结局指标

主要结局

Change from baseline performance of functional tasks to post-intervention performance of functional tasks

时间窗: Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention

Motor and process scores of the Assessment of Motor and Process Skills (AMPS) test

次要结局

  • Change from baseline grip strength to post-intervention grip strength(Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention)
  • Change from baseline range of motion in wrist and metacarpal joint to post-intervention range of motion in wrist and metacarpal joint(Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention)
  • Change from baseline forearm muscle activation/deactivation to post-intervention forearm muscle activation/deactivation(Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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