Cerebral Palsy Early Mobility Training (iMOVE)

Dynamic Supported Mobility for Infants and Toddlers With Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Conventional Therapy; Other: Dynamic Supported Mobility

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

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 gross motor function measure (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional Therapy; 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.	Other: Conventional Therapy; 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
Experimental: Dynamic Supported Mobility; 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.	Other: Dynamic Supported Mobility; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gross Motor Function Measure (GMFM-66) During Treatment Phase	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. Scores range from 0 (no volitional movement) to 100 (gross motor function of an average 5 year old). Higher scores reflect better outcomes.	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Postural Control	Early Clinical Assessment of Balance - a clinical test of balance and postural control developed for administration with young children. The minimum score is 0. The maximum score is 100. Higher scores reflect better postural control.	Baseline and 12 weeks
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. Satisfaction is rated on a scale of 1-10, with higher ratings reflecting greater parent satisfaction.	Baseline and 12 weeks
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. Scaled scores range from 0-100. Higher scores reflect greater engagement in daily life.	Baseline and 12 weeks
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 from the acceleration time series using signal processing software.	Weeks 0 and 12

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Department of Health and Human Services
• Investigators: Principal Investigator: Laura Prosser, PT, PhD, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• 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.
• Prosser LA, Pierce SR, Skorup JA, Paremski AC, Alcott M, Bochnak M, Ruwaih N, Jawad AF. Motor training for young children with cerebral palsy: A single-blind randomized controlled trial. Dev Med Child Neurol. 2024 Feb;66(2):233-243. doi: 10.1111/dmcn.15729. Epub 2023 Aug 7.
• Pierce SR, Skorup J, Kolobe THA, Smith BA, Prosser LA. Agreement Between the Gross Motor Ability Estimator-2 and the Gross Motor Ability Estimator-3 in Young Children With Cerebral Palsy. Pediatr Phys Ther. 2024 Jan 1;36(1):37-40. doi: 10.1097/PEP.0000000000001065. Epub 2023 Nov 30.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2015
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): July 13, 2020

Study Registration Dates

• First Submitted: January 8, 2015
• First Submitted That Met QC Criteria: January 13, 2015
• First Posted (Estimated): January 16, 2015

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Delay in motor skill development
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 14-011172