Dynamic-orthosis Programs for Stroke Hand Function

Condition(s) studied

Investigational drug(s) / intervention(s)

Dynamic-orthosis: Engaging in motion training at home with the use of dynamic orthoses.

Traditional stroke occupational therapy training: Traditional post-stroke movement training arranged by an occupational therapist in a medical setting.

Study summary

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

Eligibility

Primary outcome measure(s)

• 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.
• 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.
• 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.

Trial sites (1)

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