Cerebral Palsy Early Mobility Training

NCT02340026 | Completed Results

• 1 other identifier: 14-011172
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Delay in motor skill development

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Postural Control

  Baseline and 12 weeks

• Change in Physical Activity

  Weeks 0 and 12

• Change in Caregiver Satisfaction

  Baseline and 12 weeks

• Change in Child Engagement in Daily Life

  Baseline and 12 weeks

Study Arms (2)

Conventional Therapy

EXPERIMENTAL

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

Dynamic Supported Mobility

EXPERIMENTAL

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

Interventions

Dynamic Supported Mobility OTHER

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

Dynamic Supported Mobility

Conventional Therapy OTHER

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

Conventional Therapy

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• 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.

  PMID: 37550991 RESULT

• 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.

  PMID: 38033276 DERIVED

• 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.

  PMID: 30326883 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Laura A. Prosser, PT, PhD
• Organization: The Children's Hospital of Philadelphia

ProsserL@chop.edu

215-590-2495

Study Officials

• Laura Prosser, PT, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 16, 2015
• Study Start: January 15, 2015
• Primary Completion: April 1, 2019
• Study Completion: July 13, 2020
• Last Updated: November 4, 2025
• Results First Posted: September 19, 2024

Record last verified: 2025-10

Locations

US (1)