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Effects of Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy in Children With Unilateral Cerebral Palsy

Primary Purpose

Cerebral Palsy, Spastic Hemiplegic

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CIMT
H-HABIT
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic Hemiplegic focused on measuring Constraint-Induced Movement Therapy, Home-based Hand-arm Bimanual Intensive Therapy, Unilateral Cerebral Palsy

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 4 to 12 years
  • MACS level 1-3
  • Diagnosed with unilateral CP due to central nervous system lesions

Exclusion Criteria:

  • Severe cognitive dysfunction that rendered them unable to perform simple tasks (e.g., reaching, grasping
  • Untreated seizures
  • Visual or auditory problems interfering with treatment
  • Prior history of musculoskeletal disorders.
  • MACS level 4-5

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy

Constraint-induced Movement Therapy only

Arm Description

Children in experimental group will receive 2-hour clinic-based CIMT sessions, 5 days/week for 3 weeks (30 hours), and 2-hour home-based HABIT sessions, 3 days/week for 5 weeks (30 hours).

Children in experimental group will receive 2-hour clinic-based CIMT sessions, 5 days/week for 3 weeks (30 hours).

Outcomes

Primary Outcome Measures

Change from Assisting Hand Assessment (AHA) score at 2-month follow-up test
AHA is a standardized tool for children(18 months-12 years) with unilateral CP. The AHA measures the child's ability to use the affected hand to assist the unaffected hand in a variety of bimanual activities. The 15-20 minute session uses semi-structured play with specific items. A certified AHA assessor views the videorecording to score the child's displayed willingness and ability to use the weaker arm and hand on each of 22 items from 1 (= does not do) to 4 (= effective). The AHA has inter- and intra-rater reliabilities of 0.98 and 0.97 respectively and content validity established during initial development. For data analysis, we generated AHA Logit scores (as recommended in the administration manual) that transform the raw (ordinal) scores into interval level data.

Secondary Outcome Measures

Change from Baseline Pediatric Motor Activity Log (PMAL) score at 2-month follow-up test
The PMAL was derived from the Motor Activity Log, which is used as an assessment tool in adults who participated CIMT, to measure changes in upper extremity use in real life. This parental assessment tool rates the use of the children's affected upper extremities in daily activities. Twenty-two arm-hand functional tasks that are typical for children aged 7 months to 8 years (e.g., taking off socks or shoes, holding a cup) were assessed and collected as a systemic data. The test has two components: (1) how often (PMAL HO) and (2) how well (PMAL HW). Parents rate PMAL HO on a 6-point scale from 0 (not at all) to 5 (all the time) and PMAL HW from 0 (does not use) to 5 (same as the unaffected arm). This tool has a high test-retest reliability (r=0.94; P<0.01) and a high internal consistency (Cronbach's α=0.88 to 0.95).
Change from Baseline Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2) score at 2-month follow-up test
BOT-2 measures fine and gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation. The test is tailored to school-aged children and young adults among the ages of 4-21 years, who have varying motor control abilities ranging from normal to mild or moderate. The higher the score, the better the motor function is interpreted. The internal consistency and interrater reliability of BOT-2 are reported to be excellent (0.78-0.97 and >0.92).
Change from Canadian Occupational Performance Measure (COPM) score at 2-month follow-up test
The COPM was designed as an outcome measure with a semi-structured interview format and structured scoring method to assess a person's level of self-efficacy. It conceptualizes self-efficacy in terms of self-perception of performance and satisfaction with performance. The COPM uses three 10-point rating scales to rate importance, performance and satisfaction. A score value of '1' refers to a low rating (i.e. 'not important at all', not able to do it at all', 'not satisfied at all'). A score value of '10' refers to a high rating (i.e. 'extremely important', 'able to do it extremely well', 'extremely satisfied'). Summing the ratings across problems and dividing by the total number of problems derive separate total performance and satisfaction scores.
Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at 2-month follow-up test
The Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) was developed to respond to the need for an accurate and efficient functional measure with content for children and youth in multiple functional content areas. The new PEDI-CAT measures function in the three domains of Daily Activities, Mobility and Social/Cognitive for infants, children and youth from birth through 20 years of age. In addition, the PEDI-CAT's Responsibility domain measures the extent to which the caregiver or child takes responsibility for managing complex, multi-step life tasks. The higher the score, the better the functional ability is interpreted.
Change from baseline Use ratio(Accelerometer) at 2-month follow-up test
Use ratio provides a measurement that lets one compare the frequency of activity between the paretic and nonparetic arms: hours of paretic hand use/hours of nonparetic hand use. A use ratio equal to 1 indicates that the paretic and nonparetic arms are used an equal amount of time throughout the day, and values >1 indicates greater use of the paretic arm. To calculate hours of arm movement, the number of epochs with activity counts >0 will be summed and converted to hours for each arm.
Change from baseline Magnitude ratio(Accelerometer) at 2-month follow-up test
The magnitude ratio is calculated as a metric to compare the magnitude of acceleration of the arms at each time point: ln(paretic magnitude/nonparetic magnitude). The magnitude will be calculated by taking the vector magnitude of the activity counts for each epoch. The natural log will be used to avoid skewness in the ratio caused by an underestimation of the denominator. The average magnitude will be calculated for each period. A magnitude ratio near 0 indicates similar use of each arm, a negative number indicates more use of the nonparetic arm, and a positive number indicates more use of the paretic arm.
Change from baseline Bilateral magnitude(Accelerometer) at 2-month follow-up test
The bilateral magnitude is used to compare the overall movement of both arms together as a measure of bilateral arm movement: nonparetic magnitude + paretic magnitude. As with the magnitude ratio, the vector magnitude of the activity counts will be calculated for each epoch. A greater bilateral magnitude indicates greater overall movement of both arms.

Full Information

First Posted
May 23, 2021
Last Updated
May 23, 2021
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04904796
Brief Title
Effects of Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy in Children With Unilateral Cerebral Palsy
Official Title
Effects of Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy in Real-world Bimanual Hand Use in Children With Unilateral Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
May 20, 2022 (Anticipated)
Study Completion Date
June 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

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
This study evaluates the therapeutic effects of constraint-induced movement therapy (CIMT) with home-based hand-arm bimanual intensive therapy (H-HABIT) with unilateral cerebral palsy. Half of the participants will receive CIMT and H-HABIT and others will only receive CIMT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic Hemiplegic
Keywords
Constraint-Induced Movement Therapy, Home-based Hand-arm Bimanual Intensive Therapy, Unilateral Cerebral Palsy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy
Arm Type
Experimental
Arm Description
Children in experimental group will receive 2-hour clinic-based CIMT sessions, 5 days/week for 3 weeks (30 hours), and 2-hour home-based HABIT sessions, 3 days/week for 5 weeks (30 hours).
Arm Title
Constraint-induced Movement Therapy only
Arm Type
Active Comparator
Arm Description
Children in experimental group will receive 2-hour clinic-based CIMT sessions, 5 days/week for 3 weeks (30 hours).
Intervention Type
Other
Intervention Name(s)
CIMT
Intervention Description
CIMT : Constraint-Induced Movement Therapy (CIMT) is a deviation from traditional treatments, used to treat hemiplegia. Its aim is to stimulate the functional use of the affected limb and reverse the process developmental is disregard. In this method, the unaffected or less affected limb is restrained, so the person has to use the affected limb.
Intervention Type
Other
Intervention Name(s)
H-HABIT
Intervention Description
H-HABIT : Hand-Arm Bimanual Intensive Therapy (HABIT) in children with hemiplegia is a new intervention developed at Columbia University. HABIT aims to improve the use and coordination of both arms in daily function. Unlike CIMT, HABIT focuses on improving the ability to perform bimanual activities. Participants will be monitored via webcam-based software (i.e. ZOOM) while they performed the activities in their own home.
Primary Outcome Measure Information:
Title
Change from Assisting Hand Assessment (AHA) score at 2-month follow-up test
Description
AHA is a standardized tool for children(18 months-12 years) with unilateral CP. The AHA measures the child's ability to use the affected hand to assist the unaffected hand in a variety of bimanual activities. The 15-20 minute session uses semi-structured play with specific items. A certified AHA assessor views the videorecording to score the child's displayed willingness and ability to use the weaker arm and hand on each of 22 items from 1 (= does not do) to 4 (= effective). The AHA has inter- and intra-rater reliabilities of 0.98 and 0.97 respectively and content validity established during initial development. For data analysis, we generated AHA Logit scores (as recommended in the administration manual) that transform the raw (ordinal) scores into interval level data.
Time Frame
baseline and 2 months
Secondary Outcome Measure Information:
Title
Change from Baseline Pediatric Motor Activity Log (PMAL) score at 2-month follow-up test
Description
The PMAL was derived from the Motor Activity Log, which is used as an assessment tool in adults who participated CIMT, to measure changes in upper extremity use in real life. This parental assessment tool rates the use of the children's affected upper extremities in daily activities. Twenty-two arm-hand functional tasks that are typical for children aged 7 months to 8 years (e.g., taking off socks or shoes, holding a cup) were assessed and collected as a systemic data. The test has two components: (1) how often (PMAL HO) and (2) how well (PMAL HW). Parents rate PMAL HO on a 6-point scale from 0 (not at all) to 5 (all the time) and PMAL HW from 0 (does not use) to 5 (same as the unaffected arm). This tool has a high test-retest reliability (r=0.94; P<0.01) and a high internal consistency (Cronbach's α=0.88 to 0.95).
Time Frame
baseline and 2 months
Title
Change from Baseline Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2) score at 2-month follow-up test
Description
BOT-2 measures fine and gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation. The test is tailored to school-aged children and young adults among the ages of 4-21 years, who have varying motor control abilities ranging from normal to mild or moderate. The higher the score, the better the motor function is interpreted. The internal consistency and interrater reliability of BOT-2 are reported to be excellent (0.78-0.97 and >0.92).
Time Frame
baseline and 2 months
Title
Change from Canadian Occupational Performance Measure (COPM) score at 2-month follow-up test
Description
The COPM was designed as an outcome measure with a semi-structured interview format and structured scoring method to assess a person's level of self-efficacy. It conceptualizes self-efficacy in terms of self-perception of performance and satisfaction with performance. The COPM uses three 10-point rating scales to rate importance, performance and satisfaction. A score value of '1' refers to a low rating (i.e. 'not important at all', not able to do it at all', 'not satisfied at all'). A score value of '10' refers to a high rating (i.e. 'extremely important', 'able to do it extremely well', 'extremely satisfied'). Summing the ratings across problems and dividing by the total number of problems derive separate total performance and satisfaction scores.
Time Frame
baseline and 2 months
Title
Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at 2-month follow-up test
Description
The Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) was developed to respond to the need for an accurate and efficient functional measure with content for children and youth in multiple functional content areas. The new PEDI-CAT measures function in the three domains of Daily Activities, Mobility and Social/Cognitive for infants, children and youth from birth through 20 years of age. In addition, the PEDI-CAT's Responsibility domain measures the extent to which the caregiver or child takes responsibility for managing complex, multi-step life tasks. The higher the score, the better the functional ability is interpreted.
Time Frame
baseline and 2 months
Title
Change from baseline Use ratio(Accelerometer) at 2-month follow-up test
Description
Use ratio provides a measurement that lets one compare the frequency of activity between the paretic and nonparetic arms: hours of paretic hand use/hours of nonparetic hand use. A use ratio equal to 1 indicates that the paretic and nonparetic arms are used an equal amount of time throughout the day, and values >1 indicates greater use of the paretic arm. To calculate hours of arm movement, the number of epochs with activity counts >0 will be summed and converted to hours for each arm.
Time Frame
baseline and 2 months
Title
Change from baseline Magnitude ratio(Accelerometer) at 2-month follow-up test
Description
The magnitude ratio is calculated as a metric to compare the magnitude of acceleration of the arms at each time point: ln(paretic magnitude/nonparetic magnitude). The magnitude will be calculated by taking the vector magnitude of the activity counts for each epoch. The natural log will be used to avoid skewness in the ratio caused by an underestimation of the denominator. The average magnitude will be calculated for each period. A magnitude ratio near 0 indicates similar use of each arm, a negative number indicates more use of the nonparetic arm, and a positive number indicates more use of the paretic arm.
Time Frame
baseline and 2 months
Title
Change from baseline Bilateral magnitude(Accelerometer) at 2-month follow-up test
Description
The bilateral magnitude is used to compare the overall movement of both arms together as a measure of bilateral arm movement: nonparetic magnitude + paretic magnitude. As with the magnitude ratio, the vector magnitude of the activity counts will be calculated for each epoch. A greater bilateral magnitude indicates greater overall movement of both arms.
Time Frame
baseline and 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 4 to 12 years MACS level 1-3 Diagnosed with unilateral CP due to central nervous system lesions Exclusion Criteria: Severe cognitive dysfunction that rendered them unable to perform simple tasks (e.g., reaching, grasping Untreated seizures Visual or auditory problems interfering with treatment Prior history of musculoskeletal disorders. MACS level 4-5
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JEONG-YI KWON, MD, PHD
Phone
+8210-4591-1039
Email
jeongyi.kwon@samsung.com
First Name & Middle Initial & Last Name & Degree
JEONG-YI KWON, MD

12. IPD Sharing Statement

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Effects of Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy in Children With Unilateral Cerebral Palsy

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