Dynamic-orthosis Programs for Stroke Hand Function

NCT06271187 | Recruiting

• 1 other identifier: A-ER-110-507
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• Fugl-Meyer Assessment- Upper Extremity

  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.

  Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）

• Box and Block Test

  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.

  Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）

• Motor Activity Log

  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.

  Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）

Secondary Outcomes (2)

• Modified Ashworth scale

  Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）

• Upper limb joint range of motion

  Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）

Study Arms (2)

Dynamic-orthosis training group

EXPERIMENTAL

Participants will undergo traditional occupational therapy (2-3 times per week, one hour per session, for a total of six weeks), supplemented with an additional home-based dynamic orthotic therapy program (five days per week, one hour per session, for six weeks). The style of the dynamic orthosis will be selected by the researchers based on the participants' movement performance and rehabilitation goals, and it will be adjusted or replaced as their abilities progress.

Device: Dynamic-orthosis; Other: Traditional stroke occupational therapy training

Regular training group

OTHER

Participants will receive traditional occupational therapy (2-3 sessions per week, one hour per session, for a total of six weeks). The training program includes muscle strength training, reaching and grasping exercises, manual tone control, motor facilitation, and activities of daily living training. During the study period, participants will not wear any hand dynamic orthosis during training.

Other: Traditional stroke occupational therapy training

Interventions

Dynamic-orthosis DEVICE

Engaging in motion training at home with the use of dynamic orthoses.

Dynamic-orthosis training group

Traditional stroke occupational therapy training OTHER

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

Dynamic-orthosis training group; Regular training group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Onset of stroke at least three months ago;
• Upper limb Brunnstrom stage II\~IV;
• Shoulder can actively flex at least 45 degrees.

You may not qualify if:

• Affected hand has regained autonomous grasping function, able to grasp and release a tennis ball 10 times within 2 minutes;
• Joint deformity or stiffness in the affected hand that prevents the use of the dynamic orthosis;
• Diagnosis of other neurological disorders affecting motor control, such as neglect, Parkinson's disease, etc.;
• Inability to follow therapist guidance;
• Currently undergoing other specific treatments affecting motor function recovery (such as rTMS and BTX).

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• JERHAO CHANG, PhD

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JERHAO CHANG

CONTACT

+886972272012; jerhao@ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 21, 2024
• Study Start: January 22, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)