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

NCT ID: NCT05751135

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-03

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 parallel group mixed methods
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Focal muscle vibration group 1

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

Group Type EXPERIMENTAL

Focal muscle vibration

Intervention Type DEVICE

Focal muscle vibration will be provided by a longitudinal muscle vibrator on muscles of lower limb; hamstrings, quadriceps, illiopsoas, calf, gluteus maximus and medius. Each muscle will be targeted 3 times with 30 seconds time period and keeping 10 second interval.

Stretching

Intervention Type PROCEDURE

Stretching of shortened lower extremity muscle

Strengthening

Intervention Type PROCEDURE

Strengthening exercises for weak lower extremity muscles

Positioning

Intervention Type PROCEDURE

Positioning of participant to maintain a good body posture

Focal muscle vibration group 2

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

Group Type EXPERIMENTAL

Focal muscle vibration

Intervention Type DEVICE

Focal muscle vibration will be provided by a longitudinal muscle vibrator on muscles of lower limb; hamstrings, quadriceps, illiopsoas, calf, gluteus maximus and medius. Each muscle will be targeted 3 times with 30 seconds time period and keeping 10 second interval.

Stretching

Intervention Type PROCEDURE

Stretching of shortened lower extremity muscle

Strengthening

Intervention Type PROCEDURE

Strengthening exercises for weak lower extremity muscles

Positioning

Intervention Type PROCEDURE

Positioning of participant to maintain a good body posture

Control group

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

Group Type ACTIVE_COMPARATOR

Stretching

Intervention Type PROCEDURE

Stretching of shortened lower extremity muscle

Strengthening

Intervention Type PROCEDURE

Strengthening exercises for weak lower extremity muscles

Positioning

Intervention Type PROCEDURE

Positioning of participant to maintain a good body posture

Interventions

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Focal muscle vibration

Focal muscle vibration will be provided by a longitudinal muscle vibrator on muscles of lower limb; hamstrings, quadriceps, illiopsoas, calf, gluteus maximus and medius. Each muscle will be targeted 3 times with 30 seconds time period and keeping 10 second interval.

Intervention Type DEVICE

Stretching

Stretching of shortened lower extremity muscle

Intervention Type PROCEDURE

Strengthening

Strengthening exercises for weak lower extremity muscles

Intervention Type PROCEDURE

Positioning

Positioning of participant to maintain a good body posture

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Imran Amjad, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Kiran Khushnood, MSNMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Al-Farabi Special Education Center For (P.H.C)

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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REC-01289 KiranKhushnood

Identifier Type: -

Identifier Source: org_study_id

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