Whole Body VibrationNCT05739396
Core Stabalization and Rebound Therapy and CP
A study testing core stabilization in people with Whole Body Vibration and Rebound Therapy, run by Cairo University at 1 site in Egypt.
Trial summary
the study aims to compare the effect of core stabalization and rebound therapy on balance in children with hemiplegic cerebral palsy Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Whole Body Vibration, Rebound Therapy, Balance
- What is being tested?
- core stabilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 11 Jul 2023
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children diagnosed with spastic hemiplegic CP.
- Their chronological age ranged from 5 to 8 years,
- able to follow verbal commands or instructions during testing procedures,
- degree of spasticity in affected lower limbs ranged between1 to 1+ according to Modified Ashworth scale (MAS),
- they are able to understand and follow instructions given to them,
Who cannot join
- Children who had significant visual or auditory problems that may interfere with testing, - ---- patients who had contractures or fixed deformities related to the joints of the lower limbs, ---- injection with Botulinium toxin or any orthopaedic surgery in lower limbs 6m before study,
- children who were suffering from cardiopulmonary problems or epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Core Stabalization Versus Rebound Therapy on Balance in Children With Cerebral Palsy
the study aims to compare the effect of core stabalization and rebound therapy on balance in children with hemiplegic cerebral palsy
Read the detailed description
PURPOSE:
To compare the effect of core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy
BACKGROUND:
Cerebral palsy is primarily a disorder of movement and posture
HYPOTHESES:
There is no significant difference between core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy.
RESEARCH QUESTION:
Is there a significant difference between core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy?
- Conditions
- Whole Body Vibration, Rebound Therapy, Balance, cp
- Being tested
- core stabilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core stabilizationOther
Also called rebound therapy
The treatment session lasted one hour with short breaks of around 10 minutes and will be conducted three times per week for twelve successive weeks
| Study group | Role | What they receive |
|---|---|---|
| core stabalization | Experimental | The core stability exercises will be used for core stabilization training of group (A) in addition to traditional physical therapy. The core stability program included 3 levels. Each exercise lasted 5 min, and the children shifted from one exercise to the next after the complete performance of the preceding exercise. The first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10-20 repetitions), and supine twist (10-20 repetitions). The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions). Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3-5 s, followed by a slow relaxation phase, with 10-20 repetitions) Receives: Other: core stabilization |
| rebound therapy | Experimental | Rebound exercises will be applied for group B. this group will receive rebound exercise training in addition to traditional physical therapy . Rebound exercises were conducted on a mini-trampoline and BOSU ball. Passive bouncing will be conducted while the child was standing with his/her feet a shoulder-width apart. The therapist will held the child's legs while applying upward and downward movement. The bouncing started slowly. The child then will progress to include the rebound exercises, starting with active bounce, where in a hands free manner the therapist will ask the child to speed up or slow down the bounce rate according to the child's abilities Receives: Other: core stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance
it measures the degree of tilting for each axis during dynamic conditions and calculates a medial lateral stability index (MLSI); an anterior-posteriorstability index (APSI); and an overall stability index(OSI),
Measured: 12 week
Secondary outcomes (3)
gross motor function measure-88
measure gross motor function. higher scores indicate better outcome. scores are reported in percentage.
Measured: 12 week
lafayette hand held dynamometer
measure isometric muscle strength of knee flexors and extensors. higher scores reflect better outcome
Measured: 12 week
6 minute walk test
measure endurance.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Feb 2023
- Primary completion1 Jun 2023 (estimated)
- Study completion11 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Whole Body VibrationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Fahmy Hassan Al Nemr, Cairo University
- Investigators
- Faculty OP Therapy, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739396
- Sponsor's protocol ID
- P.T.REC/012/003117
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Nemr A, Kora AN. Effect of core stabilization versus rebound therapy on balance in children with cerebral palsy. Acta Neurol Belg. 2024 Jun;124(3):843-851. doi: 10.1007/s13760-023-02430-8. Epub 2024 Jan 5.
PubMed 38177509
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Core Stabalization Versus Rebound Therapy on Balance in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05739396
- Acronym / sponsor ID
- P.T.REC/012/003117
- Conditions
- Whole Body Vibration, Rebound Therapy, Balance, cp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 11 Jul 2023 (estimated)
- First posted
- 22 Feb 2023 (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.
the study aims to compare the effect of core stabalization and rebound therapy on balance in children with hemiplegic cerebral palsy
Detailed description
PURPOSE:
To compare the effect of core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy
BACKGROUND:
Cerebral palsy is primarily a disorder of movement and posture
HYPOTHESES:
There is no significant difference between core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy.
RESEARCH QUESTION:
Is there a significant difference between core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| core stabalization | Experimental | Other: core stabilizationThe core stability exercises will be used for core stabilization training of group (A) in addition to traditional physical therapy. The core stability program included 3 levels. Each exercise lasted 5 min, and the children shifted from one exercise to the next after the complete performance of the preceding exercise. The first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10-20 repetitions), and supine twist (10-20 repetitions). The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions). Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3-5 s, followed by a slow relaxation phase, with 10-20 repetitions) |
| rebound therapy | Experimental | Other: core stabilizationRebound exercises will be applied for group B. this group will receive rebound exercise training in addition to traditional physical therapy . Rebound exercises were conducted on a mini-trampoline and BOSU ball. Passive bouncing will be conducted while the child was standing with his/her feet a shoulder-width apart. The therapist will held the child's legs while applying upward and downward movement. The bouncing started slowly. The child then will progress to include the rebound exercises, starting with active bounce, where in a hands free manner the therapist will ask the child to speed up or slow down the bounce rate according to the child's abilities |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children diagnosed with spastic hemiplegic CP.
- Their chronological age ranged from 5 to 8 years,
- able to follow verbal commands or instructions during testing procedures,
- degree of spasticity in affected lower limbs ranged between1 to 1+ according to Modified Ashworth scale (MAS),
- they are able to understand and follow instructions given to them,
Key exclusion criteria (2 listed)
- Children who had significant visual or auditory problems that may interfere with testing, - ---- patients who had contractures or fixed deformities related to the joints of the lower limbs, ---- injection with Botulinium toxin or any orthopaedic surgery in lower limbs 6m before study,
- children who were suffering from cardiopulmonary problems or epilepsy.
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 |
|---|---|---|
| core stabilizationAlso: rebound therapyThe treatment session lasted one hour with short breaks of around 10 minutes and will be conducted three times per week for twelve successive weeks | Other | core stabalization, rebound therapy |
Primary outcome
balance
Time frame: 12 week
it measures the degree of tilting for each axis during dynamic conditions and calculates a medial lateral stability index (MLSI); an anterior-posteriorstability index (APSI); and an overall stability index(OSI),
3 secondary outcomes
gross motor function measure-88
Time frame: 12 week
lafayette hand held dynamometer
Time frame: 12 week
6 minute walk test
Time frame: 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 38177509Al-Nemr A, Kora AN. Effect of core stabilization versus rebound therapy on balance in children with cerebral palsy. Acta Neurol Belg. 2024 Jun;124(3):843-851. doi: 10.1007/s13760-023-02430-8. Epub 2024 Jan 5.
- Individual participant dataSharing planned: No
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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.
Faculty OP Therapy principal investigator
Cairo 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 core stabilization in people with Whole Body Vibration and Rebound Therapy, run by Cairo University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 1 Mar 2023. 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 Egypt. 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?
Results are not available in the source record.
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?
balance (time frame: 12 week). 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 NCT05739396, which also lists 1 linked publication.
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 1 Mar 2023.