Impact of Focal Muscle Vibration on Bio-psychosocial Outcomes in Cerebral Palsy

Riphah International University

Status: Completed

Conditions: Cerebral Palsy

Treatments: Procedure: Positioning; Procedure: Strengthening; Procedure: Stretching; Device: Focal muscle vibration

Study type: Interventional

Funder types: Other

Identifiers

NCT05751135

REC-01289 KiranKhushnood

Details and patient eligibility

About

This study aims to determine the effects of focal muscle vibration on bio-psychosocial outcomes in subjects with cerebral palsy. Mixed methods will be used and the study will be conducted in 2 phases; 1st phase is determining the effects of intervention, whereas second step is prediction of outcomes. A qualitative gait analysis will also be done.

Full description

The literature suggests the positive effects of focal muscle vibration on various motor components of cerebral palsy. Although there is a gap regarding it's effects with perspective of bio-psychosocial model, which will be the main focus of this study. The study will look for the effects of focal muscle vibration on biological, psychological and social aspects of subjects with cerebral palsy (CP). The intervention in form of focal muscle vibration and standard physical therapy will be provided for 12 weeks and the subjects will then be followed for 4 weeks to look for retention effects, and till 24 weeks for prediction of outcomes.

Enrollment: 111 patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed spastic diplegic cerebral palsy cases with following characteristics;
• Gross motor function classification scale levels II-IV
• Receiving standard physical therapy care

Exclusion criteria

• Severe cognitive, visual and hearing impairments.
• History of metabolic diseases.
• History of recent fractures.
• Children with severe musculo-skeletal anomalies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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111 participants in 3 patient groups

Focal muscle vibration group 1

Experimental group

Description:

Focal muscle vibration with frequency of 80 Hz will be provided 3 days along with stretching, strengthening and positioning for 8 weeks

Treatment:

Device: Focal muscle vibration

Procedure: Positioning

Procedure: Strengthening

Procedure: Stretching

Focal muscle vibration group 2

Experimental group

Description:

Focal muscle vibration with frequency of 100 Hz will be provided 3 days a week along with stretching, strengthening and positioning for 8 weeks.

Treatment:

Device: Focal muscle vibration

Procedure: Positioning

Procedure: Strengthening

Procedure: Stretching

Control group

Active Comparator group

Description:

Stretching, strengthening and positioning in 3 sessions a week for 8 weeks

Treatment:

Procedure: Positioning

Procedure: Strengthening

Procedure: Stretching