Dynamic-orthosis Programs for Stroke Hand Function

Stroke Clinical Trial

Official title:

Development of Innovative Modular 3D-Printed Dynamic Orthoses: Application Programs for Hand Function Facilitation in Patients With Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06271187
• Other study ID #: A-ER-110-507
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: National Cheng-Kung University Hospital
• Contact: JERHAO CHANG
• Phone: +886972272012
• Email: jerhao[@]ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion criteria:

1. Onset of stroke at least three months ago;

2. Upper limb Brunnstrom stage II~IV;

3. Shoulder can actively flex at least 45 degrees.

Exclusion criteria:

1. Affected hand has regained autonomous grasping function, able to grasp and release a tennis ball 10 times within 2 minutes;

2. Joint deformity or stiffness in the affected hand that prevents the use of the dynamic orthosis;

3. Diagnosis of other neurological disorders affecting motor control, such as neglect, Parkinson's disease, etc.;

4. Inability to follow therapist guidance;

5. Currently undergoing other specific treatments affecting motor function recovery (such as rTMS and BTX).

Related Conditions & MeSH terms

• Stroke

Intervention

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

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

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Modified Ashworth scale	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.	Pre-test(Week 0), post-test(Week 6), follow-up assessment(Week 10 & Week 14)
Secondary	Upper limb joint range of motion	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).	Pre-test(Week 0), post-test(Week 6), follow-up assessment(Week 10 & Week 14)