The Efficacy of Dynamic Hand Splint Treatment in Spastic Hemiparetic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-04

Study Completion Date

2019-03-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke

NCT01244243

Stroke

COMPLETED PHASE2

Robotic Modified Constraint -Induced Therapy in Patients With Spastic Hemiplegic Stroke Post Botulinum Toxin A Injection

NCT03807557

Stroke Hemiplegia, Spastic

COMPLETED NA

The Effects of Exoskeleton Robotic Training Device on Upper Extremity in Brain Injury Patients

NCT03624153

Chronic Stroke

COMPLETED NA

Kinesiotaping and Constraint Induced Movement Therapy in Subacute Stroke

NCT03682666

Stroke

COMPLETED NA

Positioning the Trunk and Upper Limb to Improve the Coordination of the Hand Movement After Stroke

NCT04782141

Stroke

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Brain Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Splint Group

1-hour task-oriented training with wearing a customized dynamic hand splint, totally 15 times in a duration of one month.

Group Type EXPERIMENTAL

Task-oriented training with a dynamic hand splint

Intervention Type BEHAVIORAL

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.

No-Splint Group

1-hour task-oriented training without wearing a customized dynamic hand splint, totally 15 times in a duration of one month.

Group Type PLACEBO_COMPARATOR

Task-oriented training without a dynamic hand splint

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* an age of 20 to 85 years
* the duration of stroke or brain injury more than 6 months
* unilateral hemiparesis with intact sound side limbs function
* the Brunnstrom's stage of both arm and hand ≥ III
* able to follow instructions, wear a dynamic hand splint and perform therapeutic activities
* wrist spasticity with a Modified Ashworth Scale score 1-3
* willing to provide the written informed consent.

Exclusion Criteria

* patients with apraxia
* cognitive impairment with a Mini-Mental State Examination (MMSE) score \< 25
* any fixed contracture of the affected wrist or fingers
* a history of peripheral nerve injury, other severe neuromuscular disease or musculoskeletal deformity change in the affected side upper extremity
* a history of alcohol or phenol injection to the affected side upper extremity
* Botulinum toxin injection to the affected side upper extremity for the treatment of spasticity within 4 months before the study
* surgical treatment for spasticity to the affected side upper extremity
* active infection
* obvious atrophy of muscles in the affected side upper extremity
* bilateral upper extremities weakness
* any dermatosis or open wounds in the affected upper extremity or an allergy to the splint.

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No