Effects of Barefoot vs. Shod Whole Body Vibration Training on Pedobarographic Evaluation, Balance, Endurance and Lower Extremity Functions in Children With Cerebral Palsy: 3-Arm Randomized Controlled Single-Blind Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Trakya University Faculty of Medicine
RECRUITING
Edirne
Contact Information
Primary
Nur Kakilli, M.D.
nurkakilli@gmail.com
+90 506 762 58 28
Backup
Filiz Tuna, Assoc. Prof.
drftuna@hotmail.com
+90 505 791 27 27
Time Frame
Start Date: 2024-10
Estimated Completion Date: 2025-12
Participants
Target number of participants: 30
Treatments
Sham_comparator: 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.
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Trakya University

This content was sourced from clinicaltrials.gov