Clinical trial NCT02887872: Electrical Stimulation and a Dynamic Orthosis for Stroke Recovery
Official title: Combining Electrical Stimulation and a Dynamic Hand Orthosis for Functional Recovery in Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
upper extremity function
rehabilitation
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria

1. have a diagnosis of ischemic or hemorrhagic stroke that occurred at least six months prior to date of participation;
2. be between 20 and 85 years of age;
3. exhibit a minimal amount of upper extremity movement (approximately 10° active wrist or digit movement);
4. be able to communicate orally and provide informed consent; and
5. be able to comprehend the responsibilities and procedures related to the study.

Exclusion Criteria:

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

Primary outcomes:
measure: Change from baseline performance of functional tasks to post-intervention performance of functional tasks
timeFrame: Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
Secondary outcomes:
measure: Change from baseline grip strength to post-intervention grip strength
timeFrame: Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
measure: Change from baseline range of motion in wrist and metacarpal joint to post-intervention range of motion in wrist and metacarpal joint
timeFrame: Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
measure: Change from baseline forearm muscle activation/deactivation to post-intervention forearm muscle activation/deactivation
timeFrame: Before and after 6-week (30 visits) electrical stimulation-dynamic hand orthosis intervention
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: Louisiana State University Health Sciences Center
name: Barbara M. Doucet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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