The Efficacy of Dynamic Hand Splint Treatment in Spastic Hemiparetic Patients

Not Applicable

Completed

• Conditions: Stroke; Brain Injuries
• Interventions: Behavioral: Task-oriented training without a dynamic hand splint; Behavioral: Task-oriented training with a dynamic hand splint

• Registration Number: NCT04441437
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2016-11-04
• Primary Completion: 2019-03-22
• Study Completion: 2019-03-22
• Status Verified: 2020-06
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-18
• Last Update Submitted: 2020-06-19
• Study First Posted: 2020-06-22
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No-Splint Group	Task-oriented training without a dynamic hand splint	1-hour task-oriented training without wearing a customized dynamic hand splint, totally 15 times in a duration of one month.
Splint Group	Task-oriented training with a dynamic hand splint	1-hour task-oriented training with wearing a customized dynamic hand splint, totally 15 times in a duration of one month.

Primary Outcome Measures

Name	Time	Method
Post-training Change of F/M ratio of ulnar nerve	Change from baseline at average 30 days	An electrophysiological examination was performed with an active recording surface electrode (G1) placed over the belly of the abductor digiti minimi of the affected side, a reference electrode (G2) placed on the phalanx of the little finger, and a ground electrode placed on the back of the hand between the stimulating and recording electrodes. Supra-maximal stimulations at the wrist 8 cm away from G1 was performed to obtain the compound muscle action potential (CMAP) and F wave of the ADM muscle with the cathode distal and proximal to the anode, respectively. The stimulation was given less than 1 Hz to avoid influences from the previous stimulus. The ratio of amplitude of the mean and the maximal F-wave to the CMAP (F/M ratio) were then calculated.
Modified Ashworth Scale (MAS)	Performed at baseline	A participant was made in sitting position with the palm of the affected side placed at the edge of table. Then his or her 2nd to 5th fingers was moved by the examiner from maximum possible flexion to maximum possible extension over a duration of about one second. All of the four fingers were done at once. The participant's wrist and elbow were then also tested in the same manner. The lowest score was zero and the highest score was 415. For statistical purposes, the MAS score '1+' is considered as 2, '2' as 3, and so on until 5.
Grip strength	Performed at baseline	For the grip strength measurement, a participant in sitting position was instructed to squeeze a dynamometer with the unaffected hand as hard as he or she can for about 3 seconds. Then the hand of affected side was tested in the same manner. Three consecutive measurements with a 3-minute interval were performed for each hand and the arithmetic mean value of the 3 trials was used for statistical analysis.
Post-training Change of Modified Ashworth Scale (MAS)	Change from baseline at average 30 days	A participant was made in sitting position with the palm of the affected side placed at the edge of table. Then his or her 2nd to 5th fingers was moved by the examiner from maximum possible flexion to maximum possible extension over a duration of about one second. All of the four fingers were done at once. The participant's wrist and elbow were then also tested in the same manner. The lowest score was zero and the highest score was 415. For statistical purposes, the MAS score '1+' is considered as 2, '2' as 3, and so on until 5.
3-Month Follow-up Change of Modified Ashworth Scale (MAS)	Change from baseline at average 90 days	A participant was made in sitting position with the palm of the affected side placed at the edge of table. Then his or her 2nd to 5th fingers was moved by the examiner from maximum possible flexion to maximum possible extension over a duration of about one second. All of the four fingers were done at once. The participant's wrist and elbow were then also tested in the same manner. The lowest score was zero and the highest score was 415. For statistical purposes, the MAS score '1+' is considered as 2, '2' as 3, and so on until 5.
3-Month Follow-up Change of Active range of motion (AROM)	Change from baseline at average 90 days	A participant in sitting position with the palm of the affected side placed at the edge of table was instructed to actively move his or her fingers and wrists as much as possible. Then the AROM of the index finger and wrist were measured by a goniometer.
Post-training Change of Grip strength	Change from baseline at average 30 days	For the grip strength measurement, a participant in sitting position was instructed to squeeze a dynamometer with the unaffected hand as hard as he or she can for about 3 seconds. Then the hand of affected side was tested in the same manner. Three consecutive measurements with a 3-minute interval were performed for each hand and the arithmetic mean value of the 3 trials was used for statistical analysis.
3-Month Follow-up Change of Grip strength	Change from baseline at average 90 days	For the grip strength measurement, a participant in sitting position was instructed to squeeze a dynamometer with the unaffected hand as hard as he or she can for about 3 seconds. Then the hand of affected side was tested in the same manner. Three consecutive measurements with a 3-minute interval were performed for each hand and the arithmetic mean value of the 3 trials was used for statistical analysis.
Post-training Change of Motor Activity Log 30(MAL)	Change from baseline at average 30 days	Using the standardized questions from the upper-extremity MAL, a participant was rated how much (Amount of Use scale, MAL-AOU) and how well (Quality of Movement scale, MAL-QOM) he or she used the upper limb of affected side to accomplish each functional activity during the past week. Both scales were anchored at 6 points (AOU scale: 0 = not used, 5 = the same as before stroke or brain injury; QOM scale: 0 = not used, 5 = normal).17, 18 A mean MAL score is the mean of all item scores.
3-Month Follow-up Change of Motor Activity Log 30(MAL)	Change from baseline at average 90 days	Using the standardized questions from the upper-extremity MAL, a participant was rated how much (Amount of Use scale, MAL-AOU) and how well (Quality of Movement scale, MAL-QOM) he or she used the upper limb of affected side to accomplish each functional activity during the past week. Both scales were anchored at 6 points (AOU scale: 0 = not used, 5 = the same as before stroke or brain injury; QOM scale: 0 = not used, 5 = normal).17, 18 A mean MAL score is the mean of all item scores.
Post-training Change of Fugl-Meyer Assessment (FMA)	Change from baseline at average 30 days	For the Fugl-Meyer Upper Extremity Assessment (FMA), a 3-graded scale with 0 as minimum and 2 as maximum was applied for grading of sensorimotor function.19 The testing procedure was conducted in a standardized manner according to the written instructions originally published and some additional general guidelines.20, 21 For motor function assessment, the Fugl-Meyer Assessment for upper extremity (FMA-UE) was used. Clear and precise instructions were given to a seated participant for each movement. The unaffected side simulated first and then the affected side was evaluated. Each activity was repeated 3 times and the highest score was recorded. The maximum total score was 66. For sensory function assessment, the Modified Fugl-Meyer sensory assessment (FMA-sensory) was used. This included tests of the light touch, temperature, tactile localization and position sensation of the upper arm, forearm, hand, thigh, calf and foot of the affected side. The maximum total score was 44.
3-Month Follow-up Change of F/M ratio of ulnar nerve	Change from baseline at average 90 days	An electrophysiological examination was performed with an active recording surface electrode (G1) placed over the belly of the abductor digiti minimi of the affected side, a reference electrode (G2) placed on the phalanx of the little finger, and a ground electrode placed on the back of the hand between the stimulating and recording electrodes. Supra-maximal stimulations at the wrist 8 cm away from G1 was performed to obtain the compound muscle action potential (CMAP) and F wave of the ADM muscle with the cathode distal and proximal to the anode, respectively. The stimulation was given less than 1 Hz to avoid influences from the previous stimulus. The ratio of amplitude of the mean and the maximal F-wave to the CMAP (F/M ratio) were then calculated.
Active range of motion (AROM)	Performed at baseline	A participant in sitting position with the palm of the affected side placed at the edge of table was instructed to actively move his or her fingers and wrists as much as possible. Then the AROM of the index finger and wrist were measured by a goniometer.
Post-training Change of Active range of motion (AROM)	Change from baseline at average 30 days	A participant in sitting position with the palm of the affected side placed at the edge of table was instructed to actively move his or her fingers and wrists as much as possible. Then the AROM of the index finger and wrist were measured by a goniometer.
Motor Activity Log 30(MAL)	Performed at baseline	Using the standardized questions from the upper-extremity MAL, a participant was rated how much (Amount of Use scale, MAL-AOU) and how well (Quality of Movement scale, MAL-QOM) he or she used the upper limb of affected side to accomplish each functional activity during the past week. Both scales were anchored at 6 points (AOU scale: 0 = not used, 5 = the same as before stroke or brain injury; QOM scale: 0 = not used, 5 = normal).17, 18 A mean MAL score is the mean of all item scores.
Fugl-Meyer Assessment (FMA)	Performed at baseline	For the Fugl-Meyer Upper Extremity Assessment (FMA), a 3-graded scale with 0 as minimum and 2 as maximum was applied for grading of sensorimotor function.19 The testing procedure was conducted in a standardized manner according to the written instructions originally published and some additional general guidelines.20, 21 For motor function assessment, the Fugl-Meyer Assessment for upper extremity (FMA-UE) was used. Clear and precise instructions were given to a seated participant for each movement. The unaffected side simulated first and then the affected side was evaluated. Each activity was repeated 3 times and the highest score was recorded. The maximum total score was 66. For sensory function assessment, the Modified Fugl-Meyer sensory assessment (FMA-sensory) was used. This included tests of the light touch, temperature, tactile localization and position sensation of the upper arm, forearm, hand, thigh, calf and foot of the affected side. The maximum total score was 44.
3-Month Follow-up Change of Fugl-Meyer Assessment (FMA)	Change from baseline at average 90 days	For the Fugl-Meyer Upper Extremity Assessment (FMA), a 3-graded scale with 0 as minimum and 2 as maximum was applied for grading of sensorimotor function.19 The testing procedure was conducted in a standardized manner according to the written instructions originally published and some additional general guidelines.20, 21 For motor function assessment, the Fugl-Meyer Assessment for upper extremity (FMA-UE) was used. Clear and precise instructions were given to a seated participant for each movement. The unaffected side simulated first and then the affected side was evaluated. Each activity was repeated 3 times and the highest score was recorded. The maximum total score was 66. For sensory function assessment, the Modified Fugl-Meyer sensory assessment (FMA-sensory) was used. This included tests of the light touch, temperature, tactile localization and position sensation of the upper arm, forearm, hand, thigh, calf and foot of the affected side. The maximum total score was 44.
F/M ratio of ulnar nerve	Performed at baseline	An electrophysiological examination was performed with an active recording surface electrode (G1) placed over the belly of the abductor digiti minimi of the affected side, a reference electrode (G2) placed on the phalanx of the little finger, and a ground electrode placed on the back of the hand between the stimulating and recording electrodes. Supra-maximal stimulations at the wrist 8 cm away from G1 was performed to obtain the compound muscle action potential (CMAP) and F wave of the ADM muscle with the cathode distal and proximal to the anode, respectively. The stimulation was given less than 1 Hz to avoid influences from the previous stimulus. The ratio of amplitude of the mean and the maximal F-wave to the CMAP (F/M ratio) were then calculated.