Spastic DiplegiaNCT04792229
Effects Of Whole Body Vibration On Lower Extremity With Diplegic Spastic Cerebral Palsy
A study testing Whole Body Viberation in people with Spastic Diplegia, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will help to determine the beneficial effects of high frequency vibration on children with diplegic cerebral palsy in improving balance ,spasticity, strength of lower limb and quality of life and a comparison between the effect of simple conventional treatment and conventional management with the usage of… Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Spastic Diplegia
- What is being tested?
- Whole Body Viberation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Oct 2020to 31 Aug 2021
- 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 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gross motor function classification level II-III
- Modified Ashworth Scale of 1-2
Who cannot join
- Auditory/ visually impaired
- Other neurological conditions e.g. spina bifida etc.
- Lower limb contractures
- Children with history of lower limb surgery in last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
This study will help to determine the beneficial effects of high frequency vibration on children with diplegic cerebral palsy in improving balance ,spasticity, strength of lower limb and quality of life and a comparison between the effect of simple conventional treatment and conventional management with the usage of vibrational therapy in cp patients.
Read the detailed description
A study "Effect of whole body vibration training on mobility in children with cerebral palsy "states Whole body vibrational therapy induce an improvement in independent ambulation and mobility of lower limb by strengthening of muscles along with the refinement of walking pattern ,gait speed and stride length in children with cerebral palsy. On the basis of our study a better treatment protocol can be designed for future in diplegic spastic cerebral palsy children.
- Conditions
- Spastic Diplegia
- Being tested
- Whole Body Viberation
- 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 ViberationOther
WBV device (frequency of 40 Hz), 3 Minute vibration with 3 minute rest
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Standing on WBV device (frequency of 40 Hz); 3 Minute vibration with 3 minute rest.
Three times repetition . Total 18-minute vibrational therapy protocol. 3 days session per week Receives: Other: Whole Body Viberation |
| Control Group | Active comparator | Stretching exercise (hip adductors ,plantar flexors, external rotators of hip \& knee flexors).
Active and passive ROMS to lower extremities. Strengthening exercises (hip and knee extensors, ankle dorsiflexes) 3 Repetitions into 3 day session per week Receives: Other: Whole Body Viberation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
the gold standard clinical tool, widely used for the measurement of the increased muscle tone and for grading the spasticity of the muscle. This scale is categorized in to 5 grades ranging from score 0 to 4. where 0 indicating normal muscular tone and 4 indicating marked spasticity of muscle. The intra class correlation coefficient for MAS is 0.92
Measured: 4 weeks
Pediatric Balance Scale
an upgraded version of berg balance scale (inter-tester reliability of 0.997 and test-retest reliability of 0.9989) used for the assessment of the balance of school age children having mild to moderate level of developmental disorders , motor impairment or with brain lesion while performing functional activities
Measured: 4 weeks
Secondary outcomes (2)
Manual Muscle Testing
To assess the muscle strength, in clinical settings as well as in research trials evaluation done either manually with Manual Muscle Testing (MMT) or instrumentally by using a dynamometers .Inter-rater reliability of MMT is ICC 0.79-0.92)
Measured: 4 weeks
CP QoL
Cp QOL have two versions :Primary caregiver (for parents of 4-12 aged children), composed of 65 items and Child self-report version (for children of 9-12 years of age ), 53 items questionnaire. Cp QOL (Caregiver ) is further Categorized into seven domains, Social wellbeing and acceptance, Participation and physical health, Feelings about functioning, Emotional wellbeing and self-esteem, Pain and impact of disability, Access to services, Family health.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start16 Oct 2020
- Primary completion31 Jul 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic DiplegiaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792229
- Sponsor's protocol ID
- REC00821 Fatima Aslam
- Status last verified
- Sep 2021
- First submitted
- 7 Mar 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Whole Body Vibration On Lower Extremity With Diplegic Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04792229
- Acronym / sponsor ID
- REC00821 Fatima Aslam
- Conditions
- Spastic Diplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will help to determine the beneficial effects of high frequency vibration on children with diplegic cerebral palsy in improving balance ,spasticity, strength of lower limb and quality of life and a comparison between the effect of simple conventional treatment and conventional management with the usage of vibrational therapy in cp patients.
Detailed description
A study "Effect of whole body vibration training on mobility in children with cerebral palsy "states Whole body vibrational therapy induce an improvement in independent ambulation and mobility of lower limb by strengthening of muscles along with the refinement of walking pattern ,gait speed and stride length in children with cerebral palsy. On the basis of our study a better treatment protocol can be designed for future in diplegic spastic cerebral palsy children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Whole Body ViberationStanding on WBV device (frequency of 40 Hz); 3 Minute vibration with 3 minute rest. Three times repetition . Total 18-minute vibrational therapy protocol. 3 days session per week |
| Control Group | Active comparator | Other: Whole Body ViberationStretching exercise (hip adductors ,plantar flexors, external rotators of hip \& knee flexors). Active and passive ROMS to lower extremities. Strengthening exercises (hip and knee extensors, ankle dorsiflexes) 3 Repetitions into 3 day session per week |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gross motor function classification level II-III
- Modified Ashworth Scale of 1-2
Key exclusion criteria (4 listed)
- Auditory/ visually impaired
- Other neurological conditions e.g. spina bifida etc.
- Lower limb contractures
- Children with history of lower limb surgery in last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Body ViberationWBV device (frequency of 40 Hz), 3 Minute vibration with 3 minute rest | Other | Control Group, Experimental Group |
Primary outcome
Modified Ashworth Scale
Time frame: 4 weeks
the gold standard clinical tool, widely used for the measurement of the increased muscle tone and for grading the spasticity of the muscle. This scale is categorized in to 5 grades ranging from score 0 to 4. where 0 indicating normal muscular tone and 4 indicating marked spasticity of muscle. The intra class correlation coefficient for MAS is 0.92
Pediatric Balance Scale
Time frame: 4 weeks
an upgraded version of berg balance scale (inter-tester reliability of 0.997 and test-retest reliability of 0.9989) used for the assessment of the balance of school age children having mild to moderate level of developmental disorders , motor impairment or with brain lesion while performing functional activities
2 secondary outcomes
Manual Muscle Testing
Time frame: 4 weeks
CP QoL
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Spastic Diplegia
Not yet recruiting
Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
Spastic Diplegia Cerebral Palsy
Active, not recruiting
Effect of Reactive Functional Motor Challenge Training on Dynamic Balance and Functional Mobility in Children With Spastic Diplegic Cerebral Palsy: A Randomized Comparative Trial.
Cerebral Palsy (CP), Spastic Diplegia Cerebral Palsy
Active, not recruiting
Oculomotor Training in Spastic Diplegia: Effects on Postural Stability and Motor Proficiency
Cerebral Palsy Spastic Diplegia
Recruiting
Effects of Proprioceptive Neuromuscular Facilitation and Task-Oriented Training on Upper Extremity Function in Children With Spastic Diplegic Cerebral Palsy
Cerebral Palsy, Spastic Diplegia
Not yet recruiting
Action Observation Therapy in Children With Spastic Diplegia
Spastic Diplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirza Obaid Baig principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Body Viberation in people with Spastic Diplegia, 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 2 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 23 Sep 2021. 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?
Modified Ashworth Scale (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2021; AzTrials last refreshed its copy on 7 Nov 2026.