Effect of 3D Printing Functional Hand Splints for Patients With Stroke

NCT06979934 | Withdrawn

• 1 other identifier: TMU-JIRB N202104007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to evaluate the effect of 3D printing functional splints on hand function for patients with stroke.Twenty stroke patients with moderate motor deficits were recruited and randomized into experimental (3D printing splint) or control (functional splint) groups for 8 weeks of treatment.The performance was assessed by a blinded assessor for two times including motor, function, and feasibility.Collected data will be analyzed with nonparametric tests by SPSS version 20.0, and alpha level was set at .05.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment-upper extremity

  The Fugl-Meyer Assessment-upper extremity (FMA-UE) measures motor impairment in the upper extremity. The assessment consists of 33 items, including movement, reflex, grasp, and coordination, and a total score of 66.The unit of measure is score.

  Change from Baseline at 8 weeks

Secondary Outcomes (7)

• Electromyography

  Change from Baseline at 8 weeks

• Dynanometer

  Change from Baseline at 8 weeks

• Range of motion of upper limb joints

  Change from Baseline at 8 weeks

• Disabilities of The Arm, Shoulder And Hand Questionnaire

  Change from Baseline at 8 weeks

• Side effects record

  Every training session, total sessions continued to 8 weeks

Study Arms (2)

3D printing splint group

EXPERIMENTAL

3D printing splint for 8 weeks of treatment (Sixty minutes for position and twenty minutes for training a time, triple times a day)

Behavioral: 3D printing splint group

functional splint group

ACTIVE COMPARATOR

functional splint for 8 weeks of treatment (Sixty minutes for position and twenty minutes for training a time, triple times a day)

Behavioral: functional splint group

Interventions

3D printing splint group BEHAVIORAL

Wear 3D printing design splint for position for 60 minutes each time, plus 20 minutes of exercise which including:(1) Raise hands for 5 minutes, and bend and straighten the elbow for 5 minutes for proximal movement exercise;(2) Wear 3D printed design hand splint and change objects according to the ability of grasp, such as hold a cup, handle, eraser, pen, etc.

3D printing splint group

functional splint group BEHAVIORAL

Wear functional splint for position for 60 minutes each time, plus 20 minutes of exercise which including:(1) Raise hands for 5 minutes, and bend and straighten the elbow for 5 minutes for proximal movement exercise;(2) Grasp the holder according the grasp ability, such as hold a cup, handle, eraser, pen, etc.

functional splint group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cerebral stroke, patients with unilateral hemiplegia
• Onset is more than three months;
• Able to understand activity instructions;
• Fugl-Meyer assessment 20-50 points

You may not qualify if:

• Age over 75 years and under 20 years old;
• Other medical diseases that affect the execution program
• Modified Ashworth Scale of Wrist and hand greater than 2 Points
• Deformed elbow, wrist and hand joints
• Treated with botulinum toxin on the upper limbs of the affected side.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Shuang Ho Hospital, Taipei Medical University

Taipei, Taiwan, 235, Taiwan

Location

Related Publications (30)

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Hsinchieh Lee

  Taipei Medical University, Taiwan, R.O.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: May 20, 2025
• Study Start: July 1, 2021
• Primary Completion: August 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)