Effects of Barefoot vs. Shod Whole Body Vibration Training in Children With Cerebral Palsy

NCT06596525 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-10

No results posted yet for this study

Summary

Cerebral palsy (CP) refers to a group of lifelong conditions that affect the development of movement and coordination that lead to activity limitations due to damage to the developing fetal or neonatal brain tissue. Although the brain lesion is static, it can lead to progressive musculoskeletal system problems. As a result of the restriction of ankle joint range of motion and many microscopic changes in the muscle structure, plantar pressure distribution is impaired in children with CP which brings about gait and balance problems. Moreover, since physical activity may be restricted due to spasticity, poor motor control, muscle weakness and balance problems; the main goals in CP rehabilitation are normalization of muscle tone, improving walking function by increasing joint range of motion, strength and balance and consequently improving mobility.

There is a need for adjunctive treatment methods with low side effect profiles that can be applied in the long term to prevent musculoskeletal complications and preserve existing functions in children with CP. Whole body vibration training (WBVT), is a therapeutic exercise method that is growing in popularity due to its ease of application, low side effect profile and non-invasiveness as an auxiliary treatment method to traditional rehabilitation programs. Although WBVT is suggested as an easily applicable and safe treatment method with home-type vibration devices; scientific evidence is still lacking and it has not yet been included in routine rehabilitation programs due to the small number of high-quality randomized controlled trials. This study aims to determine the efficacy of barefoot vs. shod WBVT in addition to the conventional physiotherapy, compared to the conventional physiotherapy alone, in children with mild-moderate CP on pedobarographic evaluation, balance, endurance and lower extremity functions. As a result of this study, it might possible to offer children with CP an accessible, safe and helpful treatment method with established protocols.

Conditions

  • Cerebral Palsy (CP)

Interventions

OTHER

Conventional physical therapy

Conventional physical therapy program will include: 1. Stretching exercises (forearm pronators, ulnar deviators, shoulder internal rotators, hip flexors and adductors, and hamstring muscle groups) 2. Strengthening exercises (ankle dorsiflexors, knee extensors, and hip flexor muscle groups) 3. Posture exercises 4. Balance and proprioception exercises 5. Walking training, obstacle crossing training, stair climbing and descending exercises

OTHER

Barefoot Whole Body Vibration Training (WBVTb)

Each WBVT session will consist of the following schedule: 3 minutes of WBVT- 2 minutes rest- 3 minutes of WBVT- 2 minutes rest- 3 minutes of WBVT- 2 minutes rest. Thus a treatment session will last 15 minutes in total. The participants will be barefoot. A specially designed walker will be used to provide support during WBVT for children who are unable to stand independently on the platform and. All exercises and WBVT sessions will be performed under the supervision of a physiotherapist and postural correction will be encouraged through visual feedback (the platform will be placed in front of a mirror) and verbal cueing. One set of WBVT along with the dynamic exercise program to be implemented on the platform is summarized below. Stage 1: Semi-squat (knees flexed 10-45º) for 1 minute Stage 2: Semi-squat +Calf raise for 1 minute Stage 3: Triceps surae stretch for 1 minute

OTHER

Shod Whole Body Vibration Training (WBVTs)

Each WBVT session will consist of the following schedule: 3 minutes of WBVT- 2 minutes rest- 3 minutes of WBVT- 2 minutes rest- 3 minutes of WBVT- 2 minutes rest. Thus a treatment session will last 15 minutes in total. The participants will wear everyday sports shoes. A specially designed walker will be used to provide support during WBVT for children who are unable to stand independently on the platform and. All exercises and WBVT sessions will be performed under the supervision of a physiotherapist and postural correction will be encouraged through visual feedback (the platform will be placed in front of a mirror) and verbal cueing. One set of WBVT along with the dynamic exercise program to be implemented on the platform is summarized below. Stage 1: Semi-squat (knees flexed 10-45º) for 1 minute Stage 2: Semi-squat +Calf raise for 1 minute Stage 3: Triceps surae stretch for 1 minute

OTHER

Sham Whole Body Vibration Training (WBVTsh)

During "Sham" WBVT; the same exercises that the intervention groups will receive on the vibration platform will be performed on the platform for the same duration (3 days per week for 15 minutes each session, over a period of 4 weeks) without the platform being activated.

Sponsors & Collaborators

  • Trakya University

    lead OTHER

Principal Investigators

  • Filiz Tuna, Assoc. Prof · Trakya University

  • Nur Kakilli, M.D. · Trakya University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-12-01
Completion
2025-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06596525 on ClinicalTrials.gov