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

NCT06596525 | Completed

• 1 other identifier: TUTF-GOBAEK 2024/322
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

cerebral palsy; whole body vibration; conventional physical therapy; balance; pedobarographic evaluation; gross motor function; spasticity

Outcome Measures

Primary Outcomes (2)

• Pedobarographic evaluation

  Static and dynamic plantar pressure parameters will be recorded via pedobarographic evaluation platform. All analysis will be carried out on a flat platform at a constant temperature of 18-22 degrees. All participants will receive clear instructions on test protocols and will be recommended to dress in a way that does not impede lower extremity movements.

  At baseline, at the end of the 4-week treatment (at 4th week), 1 month after the end of treatment (at 8th week)

• Balance

  Bipedal, unipedal and sitting balance will be evaluated using balance plates.

  At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week).

Secondary Outcomes (10)

• Bioimpedance analysis

  At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week)

• Modified Ashworth Scale (MAS) for lower extremity muscle tone

  At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week)

• Pediatric Balance Scale (PBS)

  At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week)

• Timed up and go (TUG) test

  At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week)

• Lower extremity muscle strength

  At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week)

Study Arms (3)

Group 1: Conventional physical therapy (PT) + WBVTsh (sham)

SHAM COMPARATOR

Group 1 will receive a "sham" WBVT in addition to conventional physical therapy. Over a period of 4 weeks, 3 days per week for 30 minutes each session, participants will engage in conventional physical therapy program.

Other: Conventional physical therapy; Other: Sham Whole Body Vibration Training (WBVTsh)

Group 2: Conventional physical therapy (PT) + WBVTs (shod)

EXPERIMENTAL

Over a period of 4 weeks, in addition to conventional physical therapy program, the participants will engage in WBVT on commercially available "ThinningPlate" vibration platform, 3 days per week for 15 minutes each session. Group 2 will wear everyday sports shoes during WBVT.

Other: Conventional physical therapy; Other: Shod Whole Body Vibration Training (WBVTs)

Group 3: Conventional physical therapy (PT) + WBVTb (barefoot)

EXPERIMENTAL

Over a period of 4 weeks, in addition to conventional physical therapy program, the participants will engage in WBVT on commercially available "ThinningPlate" vibration platform, 3 days per week for 15 minutes each session. Group 3 will be barefoot during WBVT.

Other: Conventional physical therapy; Other: Barefoot Whole Body Vibration Training (WBVTb)

Interventions

Barefoot Whole Body Vibration Training (WBVTb) OTHER

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

Group 3: Conventional physical therapy (PT) + WBVTb (barefoot)

Shod Whole Body Vibration Training (WBVTs) OTHER

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

Group 2: Conventional physical therapy (PT) + WBVTs (shod)

Sham Whole Body Vibration Training (WBVTsh) OTHER

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.

Group 1: Conventional physical therapy (PT) + WBVTsh (sham)

Conventional physical therapy OTHER

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

Group 1: Conventional physical therapy (PT) + WBVTsh (sham); Group 2: Conventional physical therapy (PT) + WBVTs (shod); Group 3: Conventional physical therapy (PT) + WBVTb (barefoot)

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between ages of 3 and 18
• Diagnosed with CP
• Able to walk at least 10 meters with or without assistive devices
• GMFCS level 1-3
• Able to stand independently or with self-support on a vibration platform for 3 minutes
• Able to understand verbal commands and cooperate during clinical examination

You may not qualify if:

• History of lower extremity botulinum toxin injection or surgery in the past 6 months
• Any bone fracture in the past 8 weeks
• Acute thrombosis, muscle-tendon inflammation, nephrolithiasis
• Presence of implants in the spine or lower extremities
• Pregnancy
• Presence of mental impairment, visual or hearing loss affecting balance
• History of seizures in the past 6 months
• ASH 4 spasticity/contracture in any lower extremity muscle group
• Presence of cardiovascular or pulmonary disease
• Diagnosis of dyskinetic cerebral palsy

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University Faculty of Medicine

Edirne, Merkez, 22030, Turkey (Türkiye)

Location

Related Publications (25)

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MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Filiz Tuna, Assoc. Prof

  Trakya University

  PRINCIPAL INVESTIGATOR

• Nur Kakilli, M.D.

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to study groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: The study will be conducted as a single-blind randomized controlled trial with 3 parallel arms, including 2 experimental groups and 1 control group. Participants will be randomized into 3 groups at the beginning of the study. One arm (Group 1) will be sham comparator and will receive sham WBVT in addition to conventional physical therapy. The other two arms are the experimental groups. Group 2 will receive WBVT with footwear in addition to conventional physical therapy, and Group 3 will receive WBVT with barefoot in addition to conventional physical therapy. Group 1:Conventional physical therapy (PT) + WBVTsh (sham) Group 2: PT + WBVTs (shod) Group 3: PT+ WBVTb (barefoot)

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)