Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Whole-body Vibration in Spastic Hemiplegic Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04087330
Recruitment Status : Completed
First Posted : September 12, 2019
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Brief Summary:
To target spasticity, balance and mobility whole body vibration exercises along with selected physical therapy is given to experimental group. Control group will receive only selected physical therapy that includes sstretching exercises, gait training, ffacilitation of postural reactions, ffacilitation of standing and weight shift and facilitation of standing balance by using a balance board.

Condition or disease Intervention/treatment Phase
Cerebral Palsy, Spastic Other: Group 1 Experimental group Other: Group 2 Control group Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Whole-body Vibration on Spasticity, Balance and Mobility in Spastic Hemiplegic Cerebral Palsy
Actual Study Start Date : August 15, 2019
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 Experimental group
Stretching, facilitation exercises with whole body vibration
Other: Group 1 Experimental group

Stretching exercises for Achilles tendon, hamstrings, hip flexors and adductors of lower limbs, upper abdominal and pectoralis muscles.

Facilitation of postural reactions, including: facilitation of righting, equilibrium and protective reactions from sitting on ball.

Facilitation of standing and weight shift. Facilitation of standing balance by tilting the child from standing to different directions (forward, back-ward and side-way) using a balance board.

Gait training: by forward, backward, and side-way walking between parallel bars.

Whole body vibration.


Active Comparator: Group 2 Control group
Stretching and facilitation exercises
Other: Group 2 Control group

Stretching exercises for Achilles tendon, hamstrings, hip flexors and adductors of lower limbs, upper abdominal and pectoralis muscles.

Facilitation of postural reactions, including: facilitation of righting, equilibrium and protective reactions from sitting on ball.

Facilitation of standing and weight shift. Facilitation of standing balance by tilting the child from standing to different directions (forward, back-ward and side-way) using a balance board.

Gait training: by forward, backward, and side-way walking between parallel bars.





Primary Outcome Measures :
  1. Modified Ashworth [ Time Frame: Change from Baseline spasticity to 3 months ]
    It is used to check spasticity and consists of 6 grades from 0-4

  2. 6-Minute walking test (6MWT) [ Time Frame: Change from Baseline mobility level to 3 months ]
    It is used to test mobility of participant. The 6-minute walk test (6MWT) is a standardized, self-paced walking test commonly used to assess functional ability in different populations.

  3. Paediatric Balance Scale [ Time Frame: Change from Baseline balance to 3 months ]
    The Pediatric Balance Scale (PBS), a modification of the BBS, was developed as a balance measure for children with mild to moderate motor impairments and has good test-retest and interrater reliability. The PBS is a 14-item, criterion-referenced measure and examines functional balance in the context of everyday tasks


Secondary Outcome Measures :
  1. Timed Up and Go test (TUG) [ Time Frame: Change from Baseline mobility and balance to 3 months ]
    TUG is a test used to assess a person's mobility. TUG measured the time required for an individual to stand up from a chair with armrests, walk 3 m, turn, walk back to the chair, and sit down.

  2. Sit-To-Stand (STS) test [ Time Frame: Change from Baseline mobility and balance to 3 months ]
    Sit to stand test is a reliable tool for measuring lower limb functional strength and balance ability.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ashworth scale score +1-3
  • age between 6 and 13 years,
  • able to accept and follow verbal instructions,
  • Gross Motor Function Classification System [GMFCS] levels I-III),

Exclusion Criteria:

  • unstable seizures, any treatment for spasticity or surgical procedures from 3 months (for botulinum toxin type A injections)
  • Suffering from any other condition that interfered with physical activity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087330


Locations
Layout table for location information
Pakistan
Riphah International University
Islamabad, Federal, Pakistan, 46000
Sponsors and Collaborators
Riphah International University
Investigators
Layout table for investigator information
Principal Investigator: Misbah Ghous, MSNMPT* Riphah International University
Publications:

Layout table for additonal information
Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT04087330    
Other Study ID Numbers: REC/00555 kainat Ameer
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Cerebral Palsy
Spastic
Whole body vibration
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Spasticity
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations