Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy

NCT02424526 | Completed Results

• 1 other identifier: 13-14-156
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to find the optimal dosage of home-based treadmill training needed to accelerate walking onset and to examine the long-term effects on the child's walking activity.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; treadmill training; walking

Outcome Measures

Primary Outcomes (3)

• Gross Motor Function Measure Dimension E

  The Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E). Dimension E is related to the child's gross motor skills related to walking, running and jumping and is assessed by observation. Dimension E contains 24 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension E score is 72 with a range of 0-72. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in walking, running and jumping. Change from baseline in total points, not in percentage, is reported.

  assessed at 6 weeks, 1 month, 4 months from baseline

• Walking Activity Measured by StepWatch

  StepWatch data records the child's walking activity in minutes/day. It is collected via an accelerometer attached to the distal leg and worn at all waking hours except during sleep and bath time.Higher numbers of active minutes indicate higher level of activity. Changes from baseline are reported.

  StepWatch data was collected for all awake daytime hours over a 7 day period at study onset before treadmill training commences and at 6 weeks, 1 month, 4 months.

• Gross Motor Function Measure Dimension D

  The Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E).Dimension D is a test of gross motor function related to standing ability. The child's gross motor skills related to standing are assessed by observation. The test contains 13 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension D score is 39 with a range of 0-39. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in standing. Change from baseline in total points, not in percentage, is reported.

  assessed at 6 weeks, 1 month, 4 months from baseline

Secondary Outcomes (4)

• Pediatric Evaluation of Disability Index-Mobility Subscale

  pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention

• Timed 10-meter Walk Test

  assessed at 6 weeks, at 1-month and at 4-months following the intervention

• Peabody Developmental Motor Scales-2 -Locomotion Subscale

  assessed at 6 weeks, at 1-month and at 4-months

• 1-minute Walk Test

  assessed at 6 weeks, 1 month, 4 months

Study Arms (2)

high-intensity group

ACTIVE COMPARATOR

Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks

Other: home-based treadmill training; Device: Treadmill

low-intensity group

ACTIVE COMPARATOR

Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks

Other: home-based treadmill training; Device: Treadmill

Interventions

home-based treadmill training OTHER

the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist

high-intensity group; low-intensity group

Treadmill DEVICE

high-intensity group; low-intensity group

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Signs of walking readiness as demonstrated by the ability to sit for 30 seconds when placed and to take 5 to 7 steps when supported at the trunk or arms.
• Because young children often are not formally diagnosed with CP until 2 years of age, we will include children
• who show bilateral impairment (i.e. diplegia and quadriplegia, but not hemiplegia)
• who demonstrate upper motor neuron signs (i.e. spasticity and/or hyperreflexia)
• who have been identified as high-risk for a motor disability by a physician

You may not qualify if:

• a history of uncontrolled seizures
• a diagnosis of a genetic disorder
• cardiac or orthopedic contraindications for standing and walking
• orthopedic surgery in the past 6 months
• use of spasticity-reducing medication or Botox injections in the past 6 months

Sponsors & Collaborators

• California State University, Sacramento: lead
• Seattle Children's Hospital: collaborator
• University of Puget Sound: collaborator
• Thrasher Research Fund: collaborator

Study Sites (2)

Seattle Children's Research Institute

Seattle, Washington, 98145, United States

Location

University of the Puget Sound

Tacoma, Washington, 98416, United States

Location

Related Publications (1)

• Mattern-Baxter K, Looper J, Zhou C, Bjornson K. Low-Intensity vs High-Intensity Home-Based Treadmill Training and Walking Attainment in Young Children With Spastic Diplegic Cerebral Palsy. Arch Phys Med Rehabil. 2020 Feb;101(2):204-212. doi: 10.1016/j.apmr.2019.09.015. Epub 2019 Nov 1.

  PMID: 31678223 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Limitations and Caveats

Power analysis was carried out to determine the sample size, however the population for the basis of power analysis was not as homogeneous as the subjects in this study. Not all outcome measures could be blinded.

Results Point of Contact

• Title: Katrin Mattern-Baxter, PT, DPT
• Organization: Sacramento State

kbaxter@csus.edu

19162785766

Study Officials

• David Earwicker, BA,MA

  California State University, Sacramento

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, DPT, PCS

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 23, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 2, 2020
• Results First Posted: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)