NCT04441437

The Efficacy of Dynamic Hand Splint Treatment in Spastic Hemiparetic Patients

The Efficacy of Dynamic Hand Splint Treatment in Spastic Hemiparetic Patients: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized controlled trial was designed to study the efficacy of dynamic hand splinting on spastic hemiparetic patients due to stroke or traumatic brain injury.

Detailed description

Subjects were recruited from both inpatients and outpatients who received rehabilitation programs in the Department of Physical Medicine and Rehabilitation at a regional teaching hospital in Taiwan. The participants were randomly divided into two groups: the splint group and the control group. The subjects in the splint group received 1-hour task-oriented training with wearing a customized dynamic hand splint, totally 15 times in a duration of one month plus conventional rehabilitation programs. The subjects in the control group received the same treatments but without splint used. Evaluations including Modified Ashworth Scale (MAS), active range of motion (AROM), grip strength, Fugl-Meyer Assessment (FMA), Motor Activity Log 30(MAL), and F/M ratio were performed at baseline, post-training, and 2 months later after the intervention finished, and the evaluators were blinded to the grouping of the subjects.

Conditions

• Stroke
• Brain Injuries

Interventions

Type	Name	Description
BEHAVIORAL	Task-oriented training with a dynamic hand splint	In addition to conventional rehabilitation programs (therapy-as-usual), the subject in the splint group received 1-hour task-oriented training with wearing a customized dynamic hand splint, totally 15 times in a duration of one month. The content of task-oriented training contained picking cubes from side to side with three-jaw grasp, lifting the cone to the shoulder height with the cylindrical grip and an extended elbow, picking up pegs and inserting it into the hole with palmar pinch, and grasping a soap to simulate wiping the body. Among the four tasks, two were chosen to train the subjects according to the abilities of subjects.
BEHAVIORAL	Task-oriented training without a dynamic hand splint	In addition to conventional rehabilitation programs (therapy-as-usual), the subject in the no-splint group received 1-hour task-oriented training, totally 15 times in a duration of one month. The content of task-oriented training contained picking cubes from side to side with three-jaw grasp, lifting the cone to the shoulder height with the cylindrical grip and an extended elbow, picking up pegs and inserting it into the hole with palmar pinch, and grasping a soap to simulate wiping the body. Among the four tasks, two were chosen to train the subjects according to the abilities of subjects.

Timeline

• Start date: 2016-11-04
• Primary completion: 2019-03-22
• Completion: 2019-03-22
• First posted: 2020-06-22
• Last updated: 2020-06-23