Recruiting

Treadmill Training & Vibration

Sponsor:

Georgia State University

Code:

NCT04630392

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Treadmill Training

Whole Body Vibration & Treadmill Training

Study Details

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.

Conditions

Cerebral Palsy

Study ID

NCT04630392

Start date

Nov 12, 2018

Status verified date

Mar, 2026

Completion date

Nov 20, 2026

Anticipated

Primary completion date

Nov 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group

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

Interventions

Treadmill Training

Ten minutes of treadmill walking at 110% self-selected overground walking speed

Whole Body Vibration & Treadmill Training

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

  • Overground gait walking speed [ Time Frame: immediately after intervention ]
  • Overground gait step length [ Time Frame: immediately after intervention ]
  • Overground gait dynamic knee range of motion [ Time Frame: immediately after intervention ]
  • Overground gait dynamic ankle range of motion [ Time Frame: immediately after intervention ]
  • Overground gait muscle activity as measured by electromyographic sensors [ Time Frame: immediately after intervention ]
  • Lower extremity spasticity as measured by the Modified Tardieu Test [ Time Frame: immediately after intervention ]

Central Contacts and Locations

Central contacts

Jianhua Wu, PhD

404-413-8476jwu11@gsu.edu

Gena Priest, PT, DPT, PhD

404-413-1221gpriest@gsu.edu

Locations

Georgia State University

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Jianhua Wu, PhD

404-413-8476jwu11@gsu.edu

Gena Henderson, PT, DPT, PhD

404-413-1221ghenderson2@gsu.edu

More Information

Sponsor

Georgia State University

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Georgia State University on 2026-03-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.