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Cerebral Palsy Early Mobility Training (iMOVE)

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynamic Supported Mobility
Conventional Therapy
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Delay in motor skill development

Eligibility Criteria

12 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 12-36 months of age
  • Gross motor function below the 10th percentile for age [Bayley Scales of Infant and Toddler Development (BSID), BSID-III, corrected for gestational age, if applicable, under the age of two years].
  • Diagnosis of CP or neurological sign associated with CP (i.e. spasticity).
  • Ability to initiate pulling to stand at a surface (Score of 1 on GMFM Item 52).
  • Cognitive ability to follow one-step commands.

Exclusion Criteria:

  • Secondary orthopedic, neuromuscular or cardiovascular condition unrelated to CP.
  • General muscle hypotonia, without other neurological signs associated with CP.
  • Independent walking ability (Score of 3 on GMFM Item 69 - Walks forward 10 steps).
  • At or above the 50th percentile of GMFCS Level I.
  • History of surgery or injury to the lower extremities in the past 6 months.

Sites / Locations

  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional Therapy

Dynamic Supported Mobility

Arm Description

The conventional treatment group will receive traditional, therapist-directed pediatric physical therapy. Therapy will focus on early gait training strategies and encouragement of "normal" movement patterns for walking and other age-appropriate movements, with manual guidance or correction of atypical movements from the therapist. This group may use assistive devices, orthoses, and may receive static body weight support for gait training. Therapy activities will be performed in blocks of practice, with the specific activities and level of therapist assistance tailored to each child.

Children will receive dynamic weight support during all DSM treatment time. The environment will be arranged to encourage active motor exploration, somewhat similar to a play gym for toddlers, to promote the motor variability, engagement, and error experiences that characterize the typical development of upright motor skills and walking. The floor area within 3 feet below either side of the overhead track for a distance of 20 feet (approximately 120 ft2 total) will be defined with colorful thin rubber interlocking mats and arranged with pediatric toys and activities, tailored to the child's interests and to encourage motor skills just beyond his/her current ability. The therapist will minimally assist the child as needed to perform the movements he/she initiates.

Outcomes

Primary Outcome Measures

Change in Gross Motor Function Measure (GMFM-66)
Computation of the GMFM-66 score involves statistical weighting of the raw item scores for difficulty. This score will also be used with the patient's age to determine Gross Motor Function Classification System (GMFCS) percentile rank.

Secondary Outcome Measures

Change in postural control
Using computerized posturography, participants will sit for 3-5 ten second trials on the force platform while center of pressure data are collected. This process will be repeated in kneeling and standing positions if the participant is able to maintain these positions. Center of pressure data will be interpreted using nonlinear measures of analysis.
Change in physical activity
A wireless activity monitor will be provided to the caregiver, who will be instructed on use of the monitor at home, with a goal of recording 5 total hours of the child's free play in the following week. Amount and magnitude of physical activity will be calculated using corresponding software.
Change in caregiver satisfaction
Using the Canadian Occupational Performance Measure, one caregiver of each participant will rate their child's performance on the caregiver's self-identified goals, and then rate their own (caregiver's) satisfaction with the child's performance.
Change in Child Engagement in Daily Life
One caregiver of each participant will complete the Child Engagement in Daily Life Measure to obtain a measure of the child's participation in play in daily life.
Change in Gross Motor Function Measure (GMFM-66)

Full Information

First Posted
January 8, 2015
Last Updated
December 23, 2021
Sponsor
Children's Hospital of Philadelphia
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT02340026
Brief Title
Cerebral Palsy Early Mobility Training
Acronym
iMOVE
Official Title
Dynamic Supported Mobility for Infants and Toddlers With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2015 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
July 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Department of Health and Human Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the optimal treatment duration of a novel early mobility training program (dynamic supported mobility, DSM) between 6 to 24 weeks of treatment; and to evaluate the clinical futility of this intervention compared to current rehabilitation practice.
Detailed Description
This study is a single-blind, randomized exploratory clinical trial with repeated assessments during a 24-week treatment phase and at three follow-up points over 12 months after treatment to track the developmental trajectory of participants' motor function. Gross motor ability will be compared to published percentile scores of motor function development in cerebral palsy (CP) to determine if the trajectory of predicted motor development is altered, and to outcomes of intensity-matched conventional treatment to determine if continued Phase III investigation is warranted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Delay in motor skill development

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Conventional Therapy
Arm Type
Experimental
Arm Description
The conventional treatment group will receive traditional, therapist-directed pediatric physical therapy. Therapy will focus on early gait training strategies and encouragement of "normal" movement patterns for walking and other age-appropriate movements, with manual guidance or correction of atypical movements from the therapist. This group may use assistive devices, orthoses, and may receive static body weight support for gait training. Therapy activities will be performed in blocks of practice, with the specific activities and level of therapist assistance tailored to each child.
Arm Title
Dynamic Supported Mobility
Arm Type
Experimental
Arm Description
Children will receive dynamic weight support during all DSM treatment time. The environment will be arranged to encourage active motor exploration, somewhat similar to a play gym for toddlers, to promote the motor variability, engagement, and error experiences that characterize the typical development of upright motor skills and walking. The floor area within 3 feet below either side of the overhead track for a distance of 20 feet (approximately 120 ft2 total) will be defined with colorful thin rubber interlocking mats and arranged with pediatric toys and activities, tailored to the child's interests and to encourage motor skills just beyond his/her current ability. The therapist will minimally assist the child as needed to perform the movements he/she initiates.
Intervention Type
Other
Intervention Name(s)
Dynamic Supported Mobility
Intervention Description
Dynamic weight support; Child-directed; No assistive devices, limited use of orthoses, no treadmill; Encourage high degree of error with reduced physical assistance; Encourage frequent variability in motor tasks (no redirection when moving from one activity to another); Physical therapist expertise is focused on designing a salient and challenging environment for the child's specific interests and ability level to encourage engagement, variability, challenge, and error experience, and on determining the appropriate amount of weight assistance
Intervention Type
Other
Intervention Name(s)
Conventional Therapy
Intervention Description
No or static weight support; Therapist-directed (therapist initiates); Traditional early gait training methods: use of assistive devices/orthoses and may use treadmill; Focus on producing "typical" movement patterns with extensive manual guidance/correction from therapist, prevention of falls; Therapy activities grouped into blocks of practice (i.e. repeated floor to stand practice followed by gait training); Physical therapist expertise is focused on designing and directing the specific practice activities each session, tailored to the individual child
Primary Outcome Measure Information:
Title
Change in Gross Motor Function Measure (GMFM-66)
Description
Computation of the GMFM-66 score involves statistical weighting of the raw item scores for difficulty. This score will also be used with the patient's age to determine Gross Motor Function Classification System (GMFCS) percentile rank.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in postural control
Description
Using computerized posturography, participants will sit for 3-5 ten second trials on the force platform while center of pressure data are collected. This process will be repeated in kneeling and standing positions if the participant is able to maintain these positions. Center of pressure data will be interpreted using nonlinear measures of analysis.
Time Frame
Weeks 0, 6, 12, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends
Title
Change in physical activity
Description
A wireless activity monitor will be provided to the caregiver, who will be instructed on use of the monitor at home, with a goal of recording 5 total hours of the child's free play in the following week. Amount and magnitude of physical activity will be calculated using corresponding software.
Time Frame
Weeks 0, 6, 12, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends
Title
Change in caregiver satisfaction
Description
Using the Canadian Occupational Performance Measure, one caregiver of each participant will rate their child's performance on the caregiver's self-identified goals, and then rate their own (caregiver's) satisfaction with the child's performance.
Time Frame
Weeks 0, 6, 12, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends
Title
Change in Child Engagement in Daily Life
Description
One caregiver of each participant will complete the Child Engagement in Daily Life Measure to obtain a measure of the child's participation in play in daily life.
Time Frame
Weeks 0, 6, 12, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends
Title
Change in Gross Motor Function Measure (GMFM-66)
Time Frame
Weeks 0, 6, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 12-36 months of age Gross motor function below the 10th percentile for age [Bayley Scales of Infant and Toddler Development (BSID), BSID-III, corrected for gestational age, if applicable, under the age of two years]. Diagnosis of CP or neurological sign associated with CP (i.e. spasticity). Ability to initiate pulling to stand at a surface (Score of 1 on GMFM Item 52). Cognitive ability to follow one-step commands. Exclusion Criteria: Secondary orthopedic, neuromuscular or cardiovascular condition unrelated to CP. General muscle hypotonia, without other neurological signs associated with CP. Independent walking ability (Score of 3 on GMFM Item 69 - Walks forward 10 steps). At or above the 50th percentile of GMFCS Level I. History of surgery or injury to the lower extremities in the past 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Prosser, PT, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30326883
Citation
Prosser LA, Pierce SR, Dillingham TR, Bernbaum JC, Jawad AF. iMOVE: Intensive Mobility training with Variability and Error compared to conventional rehabilitation for young children with cerebral palsy: the protocol for a single blind randomized controlled trial. BMC Pediatr. 2018 Oct 16;18(1):329. doi: 10.1186/s12887-018-1303-8.
Results Reference
derived

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Cerebral Palsy Early Mobility Training

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