Clinical trial NCT04441437: The Efficacy of Dynamic Hand Splint Treatment in Spastic Hemiparetic Patients
Official title: The Efficacy of Dynamic Hand Splint Treatment in Spastic Hemiparetic Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Brain Injuries
Keywords: spasticity
dynamic hand splint
stroke
traumatic brain injury
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: Performed at baseline
measure: Post-training Change of Modified Ashworth Scale (MAS)
timeFrame: Change from baseline at average 30 days
measure: 3-Month Follow-up Change of Modified Ashworth Scale (MAS)
timeFrame: Change from baseline at average 90 days
measure: Active range of motion (AROM)
timeFrame: Performed at baseline
measure: Post-training Change of Active range of motion (AROM)
timeFrame: Change from baseline at average 30 days
measure: 3-Month Follow-up Change of Active range of motion (AROM)
timeFrame: Change from baseline at average 90 days
measure: Grip strength
timeFrame: Performed at baseline
measure: Post-training Change of Grip strength
timeFrame: Change from baseline at average 30 days
measure: 3-Month Follow-up Change of Grip strength
timeFrame: Change from baseline at average 90 days
measure: Motor Activity Log 30(MAL)
timeFrame: Performed at baseline
measure: Post-training Change of Motor Activity Log 30(MAL)
timeFrame: Change from baseline at average 30 days
measure: 3-Month Follow-up Change of Motor Activity Log 30(MAL)
timeFrame: Change from baseline at average 90 days
measure: Fugl-Meyer Assessment (FMA)
timeFrame: Performed at baseline
measure: Post-training Change of Fugl-Meyer Assessment (FMA)
timeFrame: Change from baseline at average 30 days
measure: 3-Month Follow-up Change of Fugl-Meyer Assessment (FMA)
timeFrame: Change from baseline at average 90 days
measure: F/M ratio of ulnar nerve
timeFrame: Performed at baseline
measure: Post-training Change of F/M ratio of ulnar nerve
timeFrame: Change from baseline at average 30 days
measure: 3-Month Follow-up Change of F/M ratio of ulnar nerve
timeFrame: Change from baseline at average 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chu-Hsu Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: