Cerebral Palsy: Short-burst Interval Training

NCT03373890 | Completed Results

• 1 other identifier: R21HD077186
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the effect of short burst interval treadmill training in ambulatory children with cerebral palsy. Half the sample will receive 20 sessions of training over 4 weeks, while half will receive the training over 10 weeks.

Conditions

Cerebral Palsy Spastic Diplegia

Outcome Measures

Primary Outcomes (4)

• Change in Walking Performance High Versus Low Frequency SBLTT Groups

  Average stride per day as measured by StepWatch accelerometry. StepWatch accelerometer stride counts per day ( minimum of 8 hrs/day wearing time) were averaged a crossed 5 days (4 weekdays and 1 weekend day) to create Average Strides/day variable

  Change from baseline to immediately post SBLTT

• Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups

  Average Strides/day \> 30 strides/min as measured by StepWatch accelerometry High Versus Low Frequency SBLTT Groups

  Change from baseline to immediately post SBLTT

• Change in Walking Capacity High Versus Low Frequency SBLTT Groups

  Self selected walking speed as measured by 10 meter walk test High Versus Low Frequency SBLTT Groups

  Change from baseline to immediately post SBLT.

• Change in Walking Endurance- High Versus Low Frequency SBLTT Groups

  Distance walked during the One Minute Walk Test High Versus Low Frequency SBLTT Groups

  Change from baseline to immediately post SBLTT

Secondary Outcomes (4)

• Change in Muscle Performance -Power High Versus Low Frequency SBLTT Groups

  Change from baseline to 6 weeks post SBLTT

• Change in Muscle Performance - Strength High Versus Low Frequency SBLTT Groups

  Change from baseline to immediately post SBLTT

• Change in Muscle Architecture-High Versus Low Frequency SBLTT Groups

  Change from baseline to immediately post SBLTT

• Change in Muscle Architecture-hypertrophy High Versus Low Frequency SBLTT Groups

  Change from baseline to immediately post SBLTT

Study Arms (2)

Short burst Interval Treadmill Training High Frequency

EXPERIMENTAL

Participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 5x/week for 4 weeks

Behavioral: Short Burst Interval Locomotor Treadmill Training (SBLTT)

Short Burst Interval Treadmill Training Low Frequency

ACTIVE COMPARATOR

Participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 2x/week for 10 weeks

Behavioral: Short Burst Interval Locomotor Treadmill Training (SBLTT)

Interventions

Short Burst Interval Locomotor Treadmill Training (SBLTT) BEHAVIORAL

SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT.,

Short Burst Interval Treadmill Training Low Frequency; Short burst Interval Treadmill Training High Frequency

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ambulatory children with cerebral palsy Spasticity primary movement disorder Bilateral motor impairment (Diplegia) Gross Motor Function Classification System Levels II and III

You may not qualify if:

• undergone orthopedic or neurosurgery less than 12 months prior injection therapies (phenol, botulinum toxin) less than 3 months prior

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98115, United States

Location

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: Kristie Bjornson, PT, PhD
• Organization: SeattleChildrens

kristie.bjornson@seattlechildrens.org

206-884-2066

Study Officials

• James Hendricks, PhD

  Seattle Children's Hospital

  STUDY DIRECTOR

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
• Masking Details: Muscle function assessor masked to frequency group, Muscle architecture captured via ultrasound Community walking activity collected by accelerometry, thus non-human data collection
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pediatrics

Model Details: Pre/post intervention design with participants randomized to two different frequency of intervention

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 14, 2017
• Study Start: August 1, 2014
• Primary Completion: July 31, 2016
• Study Completion: July 31, 2016
• Last Updated: July 10, 2019
• Results First Posted: July 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)