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Effects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treadmill Training
Whole Body Vibration & Treadmill Training
Sponsored by
Georgia State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a medical diagnosis of spastic CP
  • a GMFCS level of I, II, or III
  • age of 6-17 years at the time of data collection

Exclusion Criteria:

  • history of musculoskeletal injury within the past 3 months
  • history of Botox injections to the lower extremities within the past 3 months
  • history of significant cardiac abnormalities and/or uncontrolled seizures
  • any cognitive or behavioral issues that prevent the subject from safely following instructions while walking on the treadmill

Sites / Locations

  • Georgia State UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

There are two intervention groups: treadmill walking only, whole-body vibration plus treadmill walking.

Outcomes

Primary Outcome Measures

Overground gait walking speed
Measured in m/s from kinematic motion capture data
Overground gait step length
Measured in cm from kinematic motion capture data
Overground gait dynamic knee range of motion
Measured in degrees from kinematic motion capture data
Overground gait dynamic ankle range of motion
Measured in degrees from kinematic motion capture data
Overground gait muscle activity as measured by electromyographic sensors
integrated area per gait cycle at the following muscles: biceps femoris, vastus lateralis, lateral gastrocnemius, tibialis anterior
Lower extremity spasticity as measured by the Modified Tardieu Test
including R1 and R2 joint angles as well as qualitative score

Secondary Outcome Measures

Full Information

First Posted
September 25, 2020
Last Updated
March 2, 2023
Sponsor
Georgia State University
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1. Study Identification

Unique Protocol Identification Number
NCT04630392
Brief Title
Effects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy
Official Title
Effects of the Addition of a Single Bout of Whole-Body Vibration to a Single Bout of Treadmill Training on Gait and Spasticity in Ambulatory Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Whole-body vibration (WBV) and treadmill training (TT) are commonly-utilized rehabilitation interventions for children with neuromotor disorders. WBV has been shown in the literature to positively affect gait and lower body spasticity in this population. However, the effects of a single session of WBV are generally transient, lasting between ten minutes and two hours. Thus, it may be necessary to combine WBV with another intervention to reinforce improved movement patterns and maximize its potential benefits. Therefore, the aim of this study is to investigate the effects of the addition of a single bout of WBV to a single bout of TT on the lower extremity spasticity and gait parameters of ambulatory children with CP.
Detailed Description
Whole-body vibration (WBV) and treadmill training (TT) are commonly-utilized rehabilitation interventions for children with neuromotor disorders. The evidence supporting the use of TT in children with cerebral palsy (CP) remains inconclusive, but WBV has been shown in the literature to positively affect gait and lower body spasticity in this population. However, the effects of a single session of WBV are generally transient, lasting between ten minutes and two hours. Thus, it may be necessary to combine WBV with another intervention to reinforce improved movement patterns and maximize its potential benefits. Therefore, the aim of this study is to investigate the effects of the addition of a single bout of WBV to a single bout of TT on the lower extremity spasticity and gait parameters of ambulatory children with CP. The investigators plan to recruit 20 children between the ages of 6 and 17 with spastic CP. Subjects will complete a 10-minute bout of TT at 110% of their preferred overground (OG) walking speed, rest for 15 minutes, and then complete a 12-minute bout of WBV at 20Hz and 2mm followed by a second 10-minute bout of TT at the same speed. OG gait characteristics, including spatiotemporal parameters, joint kinematics, and electromyographic (EMG) parameters, will be collected at 5 time points: before the first bout of TT, immediately following the first bout of TT, before WBV, immediately following WBV, and immediately following the second bout of TT. Lower extremity spasticity will be assessed using multiple methods at the same time points. Changes in gait parameters and spasticity will be assessed using a one-way repeated measures ANOVA and a series of dependent t-tests. Significant level will be set at α = 0.05. The investigators anticipate that acute improvements in OG gait parameters will be greater following the combined bout of WBV and TT than the bout of TT alone. The investigators expect this to be due to the reduction of lower extremity spasticity following WBV, which should allow for more normalized gait patterns during TT and improve carryover to OG gait. Further, the investigators expect to gain insight into the mechanisms responsible for spasticity reduction following WBV which will allow for the making of informed decisions regarding clinical rehabilitative protocols involving WBV and TT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Self-controlled study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
There are two intervention groups: treadmill walking only, whole-body vibration plus treadmill walking.
Intervention Type
Other
Intervention Name(s)
Treadmill Training
Intervention Description
Ten minutes of treadmill walking at 110% self-selected overground walking speed
Intervention Type
Other
Intervention Name(s)
Whole Body Vibration & Treadmill Training
Intervention Description
Eight bouts of 90 seconds of vibration at 20 Hz and an amplitude of 2 mm on a Galileo Med-L side-to-side-alternating WBV plate (StimDesigns LLC, Carmel, CA, USA) followed by ten minutes of treadmill walking at 110% self selected overground walking speed.
Primary Outcome Measure Information:
Title
Overground gait walking speed
Description
Measured in m/s from kinematic motion capture data
Time Frame
immediately after intervention
Title
Overground gait step length
Description
Measured in cm from kinematic motion capture data
Time Frame
immediately after intervention
Title
Overground gait dynamic knee range of motion
Description
Measured in degrees from kinematic motion capture data
Time Frame
immediately after intervention
Title
Overground gait dynamic ankle range of motion
Description
Measured in degrees from kinematic motion capture data
Time Frame
immediately after intervention
Title
Overground gait muscle activity as measured by electromyographic sensors
Description
integrated area per gait cycle at the following muscles: biceps femoris, vastus lateralis, lateral gastrocnemius, tibialis anterior
Time Frame
immediately after intervention
Title
Lower extremity spasticity as measured by the Modified Tardieu Test
Description
including R1 and R2 joint angles as well as qualitative score
Time Frame
immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a medical diagnosis of spastic CP a GMFCS level of I, II, or III age of 6-17 years at the time of data collection Exclusion Criteria: history of musculoskeletal injury within the past 3 months history of Botox injections to the lower extremities within the past 3 months history of significant cardiac abnormalities and/or uncontrolled seizures any cognitive or behavioral issues that prevent the subject from safely following instructions while walking on the treadmill
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Wu, PhD
Phone
404-413-8476
Email
jwu11@gsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gena Henderson, PT, DPT, PhD
Phone
404-413-1221
Email
ghenderson2@gsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhua Wu, PhD
Organizational Affiliation
Georgia State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia State University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Wu, PhD
Phone
404-413-8476
Email
jwu11@gsu.edu
First Name & Middle Initial & Last Name & Degree
Gena Henderson, PT, DPT, PhD
Phone
404-413-1221
Email
ghenderson2@gsu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy

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