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The Efficacy of Dynamic Hand Splint Treatment in Spastic Hemiparetic Patients

Primary Purpose

Stroke, Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Task-oriented training with a dynamic hand splint
Task-oriented training without a dynamic hand splint
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring spasticity, dynamic hand splint, stroke, traumatic brain injury

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Splint Group

    No-Splint Group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Modified Ashworth Scale (MAS)
    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.
    Post-training Change of Modified Ashworth Scale (MAS)
    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)
    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.
    Active range of motion (AROM)
    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)
    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.
    3-Month Follow-up Change of Active range of motion (AROM)
    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.
    Grip strength
    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 Grip strength
    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
    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.
    Motor Activity Log 30(MAL)
    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 Motor Activity Log 30(MAL)
    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)
    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)
    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.
    Post-training Change of Fugl-Meyer Assessment (FMA)
    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)
    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
    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.
    Post-training Change of F/M ratio of ulnar nerve
    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.
    3-Month Follow-up Change of F/M ratio of ulnar nerve
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 16, 2020
    Last Updated
    June 19, 2020
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04441437
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 4, 2016 (Actual)
    Primary Completion Date
    March 22, 2019 (Actual)
    Study Completion Date
    March 22, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Brain Injuries
    Keywords
    spasticity, dynamic hand splint, stroke, traumatic brain injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Splint Group
    Arm Type
    Experimental
    Arm Description
    1-hour task-oriented training with wearing a customized dynamic hand splint, totally 15 times in a duration of one month.
    Arm Title
    No-Splint Group
    Arm Type
    Placebo Comparator
    Arm Description
    1-hour task-oriented training without wearing a customized dynamic hand splint, totally 15 times in a duration of one month.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Task-oriented training with a dynamic hand splint
    Intervention Description
    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
    Intervention Name(s)
    Task-oriented training without a dynamic hand splint
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Modified Ashworth Scale (MAS)
    Description
    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.
    Time Frame
    Performed at baseline
    Title
    Post-training Change of Modified Ashworth Scale (MAS)
    Description
    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.
    Time Frame
    Change from baseline at average 30 days
    Title
    3-Month Follow-up Change of Modified Ashworth Scale (MAS)
    Description
    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.
    Time Frame
    Change from baseline at average 90 days
    Title
    Active range of motion (AROM)
    Description
    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.
    Time Frame
    Performed at baseline
    Title
    Post-training Change of Active range of motion (AROM)
    Description
    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.
    Time Frame
    Change from baseline at average 30 days
    Title
    3-Month Follow-up Change of Active range of motion (AROM)
    Description
    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.
    Time Frame
    Change from baseline at average 90 days
    Title
    Grip strength
    Description
    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.
    Time Frame
    Performed at baseline
    Title
    Post-training Change of Grip strength
    Description
    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.
    Time Frame
    Change from baseline at average 30 days
    Title
    3-Month Follow-up Change of Grip strength
    Description
    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.
    Time Frame
    Change from baseline at average 90 days
    Title
    Motor Activity Log 30(MAL)
    Description
    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.
    Time Frame
    Performed at baseline
    Title
    Post-training Change of Motor Activity Log 30(MAL)
    Description
    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.
    Time Frame
    Change from baseline at average 30 days
    Title
    3-Month Follow-up Change of Motor Activity Log 30(MAL)
    Description
    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.
    Time Frame
    Change from baseline at average 90 days
    Title
    Fugl-Meyer Assessment (FMA)
    Description
    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.
    Time Frame
    Performed at baseline
    Title
    Post-training Change of Fugl-Meyer Assessment (FMA)
    Description
    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.
    Time Frame
    Change from baseline at average 30 days
    Title
    3-Month Follow-up Change of Fugl-Meyer Assessment (FMA)
    Description
    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.
    Time Frame
    Change from baseline at average 90 days
    Title
    F/M ratio of ulnar nerve
    Description
    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.
    Time Frame
    Performed at baseline
    Title
    Post-training Change of F/M ratio of ulnar nerve
    Description
    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.
    Time Frame
    Change from baseline at average 30 days
    Title
    3-Month Follow-up Change of F/M ratio of ulnar nerve
    Description
    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.
    Time Frame
    Change from baseline at average 90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chu-Hsu Lin, MD
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Efficacy of Dynamic Hand Splint Treatment in Spastic Hemiparetic Patients

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