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Cerebral PalsyNCT06461845

Whole Body Vibration Effect on Trunk Control, Functional Performance and Selective Control

A study testing Whole Body Vibration group and conventional therapy in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Permanent neurological disorders such as cerebral palsy lead to problems with motor, sensory, and cognitive functions, which in turn limit one's ability to do certain activities. While the exact causes of cerebral palsy differ from child to child, anoxia-induced brain injury is a major cause of the disorder. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Whole Body Vibration group and conventional therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 sitePakistan
Study dates
30 May 2024to 30 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • • Childrens who follow verbal command
  • Childrens who can stand or walk alone (either with altered pattern)
  • Age limit: 6 -12 years
  • GMFCS I \& II
  • Diplegic Cerebral palsy

Who cannot join

  • • Childrens with history of fracture in last 6 months
  • Childrens with fixed contracture or other deformity of lower limb
  • Childrens having visual or auditory impairments
  • Selective dorsal rhizotomy or botulinum toxin injection to lower extremities within past six months

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Pakistan Society for Rehabilitation of Disabled

    Lahore, 54792

Other trials in Pakistan

About this study

Official title: Effect of Whole Body Vibration Effect on Trunk Control, Functional Performance and Selective Control of Lower Extremity in Children With Cerebral Palsy

Permanent neurological disorders such as cerebral palsy lead to problems with motor, sensory, and cognitive functions, which in turn limit one's ability to do certain activities. While the exact causes of cerebral palsy differ from child to child, anoxia-induced brain injury is a major cause of the disorder. The body parts affected, tone, and involuntary motions are used to categorise cerebral palsy. Among all the forms, spastic CP is the most prevalent. In individuals with CP, postural stabilisation and adaptations of the head, trunk, pelvic, and shoulder girdles grow more slowly. The primary problem with CP children is their gross movement pattern, which prevents them from performing single joint movements. Muscle strength increases significantly with WBV exercise training, which also reduces spasticity and enhances CP children's motor function. This study is important because it will determine whether WBV improves trunk control, functional performance, and lower limb selective control.

Data from Rising Sun Institute will be gathered for this randomised clinical trial. 38 patients will be included in the study. The study's inclusion criteria will include CP children with ages between 6 and 12 years old, those who can stand or walk alone (even with unusual gait patterns), GMFCS I and II, and children with diplegic cerebral palsy. Children with cerebral palsy (CP) who have had a lower limb fracture, fixed contracture, or other deformity, as well as those who have had a botulinum toxin injection or selective dorsal rhizotomy within the last six months, will not be eligible. Stretching exercises, strengthening exercises, trunk control facilitation, and rightening reaction facilitation will be the specific physical therapy treatments administered to group A. In addition, group B will receive WBV in addition to the specific physical therapy treatments (stretching exercises, strengthening exercises, trunk control facilitation, and rightening reaction facilitation). For two months, the 30-minute sessions will be held three times a week. The Modified Trost Test will test selective lower limb control, the PEDI scale will assess functional performance, and the Trunk Control Measurement Scale will monitor trunk stability before and after sessions. SPSS version 26 will be utilised for data analysis.

Conditions
Cerebral Palsy
Being tested
Whole Body Vibration group, conventional therapy
Keywords
Whole body vibration, cerebral palsy, trunk control, muscle performance, selective motor control
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole Body Vibration groupOther

    This group will be given WBV training session, by using a WBV platform was conducted to the study group. The wBV program comprises various positions such as the child stands in an erect position, sitting, and in kneeling position on vibrating platform. This platform vibrates horizontally at a frequency ranged from 10 to 25 Hz. The participants had to carry out each position for 2 min in the first month, and then it was increased to 3 min in the second month. The rest period between each position was 1 min in the first month, then it became half a minute in the second month. The duration of the vibration exposure was 10 min.

  • conventional therapyOther

    This group will be provided with the conventional physical therapy. To this, stretching activities to keep up muscle elasticity particularly Achilles tendon, hamstring muscles, hip flexors and adductors; strength training to hip flexor, knee extensor, and ankle dorsiflexor;

Study groups in NCT06461845
Study groupRoleWhat they receive
whole body vibration groupExperimentalNot described
Receives: Other: Whole Body Vibration group; Other: conventional therapy
conventional therapy groupActive comparatorNot described
Receives: Other: conventional therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. .Trunk Control Measurement Scale (TCMS) for trunk control

    To access trunk control in CP child we choose TCMS, it assesses seated trunk control in three dimensions static sitting balance, dynamic sitting balance and dynamic reaching. The maximum score is 58 points. The items are scored from 0 to 3, with 0 being the inability to perform the task and 3 being the complete performance of the item (20).

    Measured: Baseline to 8 weeks

  2. Modified Trost Test for selective control of lower extremity

    This test is used for assessment of selective motor control of lower extremity. It is a 3-point scale with assessment of ankle dorsiflexion, knee extension, hip flexion and hip abduction.

    • 0 point for Only patterned movement observed (total synergy)
    • 1 for Partially isolated movement observed (partial synergy)
    • 2 for Completely isolated movement observed (no synergy)

    Measured: Baseline to 8 weeks

  3. PEDI SCALE for functional performance

    This scale is use for assessment of functional performance. It is composed of 197 items, subdivided into three domains(22).

    Mobility (59 items, involving tub transfers, toilet transfers, indoor and outdoor locomotion, and climbing stairs); Self-care (73 items involving eating, dressing, grooming); Social function (65 items related to communication with comprehension and expression, problem-solving, interactions with peers and adults and safety awareness).

    Each item scores (0) for "unable" to perform the activities or (1) for "capable

    Measured: Baseline to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2024
  2. Study start30 May 2024
  3. Primary completion15 Aug 2024
  4. Study completion30 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06461845
Sponsor's protocol ID
REC/PCR&AHS/23/0771
Status last verified
Mar 2025
First submitted
12 Jun 2024
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Annino G, Alashram AR, Alghwiri AA, Romagnoli C, Messina G, Tancredi V, Padua E, Mercuri NB. Effect of segmental muscle vibration on upper extremity functional ability poststroke: A randomized controlled trial. Medicine (Baltimore). 2019 Feb;98(7):e14444. doi: 10.1097/MD.0000000000014444.

    PubMed 30762754

  • Ali YMM, Elhadidy EI, Abdou RGE, Darwish SY. EFFECT OF WHOLE BODY VIBRATION ON QUADRICEPS MUSCLE PERFORMANCE IN HEMIPARETIC CHILDREN. 11. Ahmadizadeh Z, Khalili MA, Ghalam MS, Mokhlesin M. Effect of whole body vibration with stretching exercise on active and passive range of motion in lower extremities in children with cerebral palsy: A randomized clinical trial. Iranian Journal of Pediatrics. 2019;29(5)

  • Telford D, Vesey RM, Hofman PL, Gusso S. The Effect of Vibration Therapy on Walking Endurance in Children and Young People With Cerebral Palsy: Do Age and Gross Motor Function Classification System Matter? Arch Rehabil Res Clin Transl. 2020 Jun 20;2(3):100068. doi: 10.1016/j.arrct.2020.100068. eCollection 2020 Sep.

    PubMed 33543094

Questions about this trial

What is this clinical trial studying?

A study testing Whole Body Vibration group and conventional therapy in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

.Trunk Control Measurement Scale (TCMS) for trunk control (time frame: Baseline to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06461845, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

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