Effects of Barefoot vs. Shod Whole Body Vibration Training in Children With Cerebral Palsy
NCT ID: NCT06596525
Last Updated: 2025-11-25
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2024-10-01
2026-02-28
Brief Summary
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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.
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Detailed Description
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In children with CP, while proximal motor function of the lower extremities is generally preserved; calf muscles, which are well-known to greatly influence postural control, are particularly affected by primary impairments such as spasticity, selective motor control deficits and weakness. As gastrocnemius muscle stiffness increases with growth, it undergoes shortening and atrophy; while its antagonist muscle, the tibialis anterior, often becomes weak. In later ages, ankle joint of motion progressively decreases, accompanied by numerous microscopic changes in muscle structure leading to plantar flexion contractures in children with CP. This results in abnormal plantar pressure distribution, contributing to gait and balance problems. Increased plantar flexor activity or knee flexion increases load on the forefoot. Significant differences have been reported in weight distribution on the feet of children with hemiplegic CP. Previous studies suggest that children with CP exhibit distinct plantar pressure patterns.
WBVT is an emerging therapeutic exercise method in addition to traditional rehabilitation, gaining popularity due to its ease of application and low side effect profile. In WBVT, vibration motion generated by the platform stimulates a movement pattern similar to human gait which results in activation of proprioceptive spinal circuits, leading to compensatory rhythmic muscle contractions in the lower extremities and trunk. Studies conducted on adult, adolescent and pediatric individuals with CP report positive effects of WBVT on gross motor function, balance, muscle strength, muscle tone, spasticity, proprioceptive perception, functional activities and walking. In brief, WBVT stands out as a safe, non-pharmacological method to increase muscle mass in specific pediatric populations.
Enhancing balance and lower extremity function is crucial for improving mobilization, a key goal in CP treatment. CP is commonly approached as a pediatric issue, but approximately 90% of individuals with CP reach adulthood and their life expectancy is similar to that of general population. Given that CP is a lifelong condition, there is a need for adjunctive therapies with low side effect profiles that can be applied in the long term to prevent complications and preserve existing functions. WBVT emerges as a promising adjunctive therapy for inclusion in rehabilitation programs for CP. It is non-invasive, easy to administer and has low side effect profile. WBVT can be applied quickly and conveniently with home-based devices, making it a practical treatment option.
Not only is the number of randomized controlled trials limited, but existing studies also have shortcomings such as a lack of specification regarding footwear (shoes/socks/barefoot/assistive devices) used during WBVT, as well as addressing technical terms (frequency, peak-to-peak displacement, amplitude, etc.), type of vibration (side alternating/synchronous), and the types of exercises (static or dynamic) performed on the platform.
In this study, participants will be selected from children diagnosed with CP who are followed up at the pediatric rehabilitation clinic of Trakya University Department of Physical Medicine and Rehabilitation and who meet the inclusion and exclusion criteria. Participants will be randomized into 3 groups at the beginning of the study. Age, gender, more affected extremity, use of orthoses/assistive devices, Gross Motor Function Classification System (GMFCS) level, history of orthopedic surgery and presence of comorbidities will be recorded for all participants. Written informed consent will be obtained from the families of all participants.
Group 1 will receive sham WBVT in addition to conventional physical therapy program. Groups 2 and 3 will receive WBVT with footwear and barefoot, respectively in addition to conventional physical therapy program. 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. By addressing the gaps in the literature and establishing the effects of WBVT, it is anticipated that WBVT will contribute to improving mobility, balance and overall quality of life for children with CP. Detailed protocol presentation in this study will contribute to pediatric rehabilitation in clinical practice and shed light on future research.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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)
TREATMENT
SINGLE
Study Groups
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Group 1: Conventional physical therapy (PT) + WBVTsh (sham)
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.
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
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.
Group 2: Conventional physical therapy (PT) + WBVTs (shod)
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.
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
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
Group 3: Conventional physical therapy (PT) + WBVTb (barefoot)
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.
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
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
Interventions
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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
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
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
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.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with CP
3. Able to walk at least 10 meters with or without assistive devices
4. GMFCS level 1-3
5. Able to stand independently or with self-support on a vibration platform for 3 minutes
6. Able to understand verbal commands and cooperate during clinical examination
Exclusion Criteria
2. Any bone fracture in the past 8 weeks
3. Acute thrombosis, muscle-tendon inflammation, nephrolithiasis
4. Presence of implants in the spine or lower extremities
5. Pregnancy
6. Presence of mental impairment, visual or hearing loss affecting balance
7. History of seizures in the past 6 months
8. ASH 4 spasticity/contracture in any lower extremity muscle group
9. Presence of cardiovascular or pulmonary disease
10. Diagnosis of dyskinetic cerebral palsy
3 Years
18 Years
ALL
No
Sponsors
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Trakya University
OTHER
Responsible Party
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FİLİZ TUNA
Assoc. Prof.
Principal Investigators
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Filiz Tuna, Assoc. Prof
Role: PRINCIPAL_INVESTIGATOR
Trakya University
Nur Kakilli, M.D.
Role: PRINCIPAL_INVESTIGATOR
Trakya University
Locations
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Trakya University Faculty of Medicine
Edirne, Merkez, Turkey (Türkiye)
Countries
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References
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Other Identifiers
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TUTF-GOBAEK 2024/322
Identifier Type: -
Identifier Source: org_study_id
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