Dynamic-orthosis Programs for Stroke Hand Function

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT06271187
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors.

Detailed Description

This study is a randomized controlled intervention trial. Participants are recruited from two medical centers in Taiwan and undergo a continuous 6-week intervention for post-stroke movement rehabilitation. The control group receives traditional stroke occupational therapy rehabilitation. The experimental group, in addition to traditional treatment, supplements their therapy with the use of modular 3D printed dynamic orthoses developed by the research team for home training. Both groups undergo two effectiveness follow-up assessments, one month and two months after the intervention.

Study Timeline

• Study Start: 2024-01-22
• Study First Submitted: 2024-01-27
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Box and Block Test	Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）	The Box and Block Test (BBT) is a tool used to assess manual dexterity, known for its short assessment time, simplicity, and ease of understanding. It exhibits excellent test-retest reliability (0.96) and inter-rater reliability (0.99). The test involves counting the number of cubes a person can move within one minute, with a higher quantity indicating better functionality. The size of the cubes is 2.5cm³, and there are a total of 150 cubes. Past research suggests a Minimal Clinically Important Difference (MCID) value of 5.5 cubes for the BBT.
Fugl-Meyer Assessment- Upper Extremity	Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）	The Fugl-Meyer Assessment-Upper Extremity (FMA-UE) is a specialized test designed for evaluating motor function in individuals post-stroke. It employs an ordinal scale to score 33 items related to upper limb movements, with a total score of 66 points. Each item reflects movements indicative of motor function in post-stroke hemiparetic patients, covering a range from proximal to distal joints.; The FMA-UE has undergone extensive testing and has been found to possess excellent psychometric properties. It is considered an effective assessment tool for upper limb motor function, particularly suitable for chronic stroke patients with moderate to severe impairments.
Motor Activity Log	Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）	The Motor Activity Log (MAL) is a questionnaire-based assessment that evaluates the amount of use (AOU) and quality of movement (QOM) of the affected side in daily activities. The scoring for amount of use ranges from 0 (never using the affected hand in the activity) to 5 (always using the affected hand in the activity). Quality of movement is scored from 0 (unable to use the affected hand) to 5 (movement quality comparable to pre-stroke). There are a total of 28 items in the assessment, recording the average scores for both amount of use and movement quality for each item. Previous research has demonstrated good construct validity for this scale, with a Minimal Clinically Important Difference (MCID) ranging from 1.0 to 1.1 points.

Secondary Outcome Measures

Name	Time	Method
Modified Ashworth scale	Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）	The MAS (Modified Ashworth Scale) utilizes quick stretching to assess muscle tone, with testing conducted on the upper limb, specifically the hand, elbow, wrist, and fingers. For ease of statistical analysis, the scale is converted into numerical values ranging from 0 to 5, with lower scores indicating lower muscle tone.
Upper limb joint range of motion	Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）	This study will use a goniometer to measure the upper limb joint range of motion in patients, including the shoulder, elbow, wrist, and fingers. The measurements encompass passive range of motion (PROM), active range of motion without wearing orthosis (AROM), and active-assisted range of motion with orthosis assistance (AAROM).

Trial Locations

Locations (1)

National Cheng Kung University; 🇨🇳 Tainan, Taiwan