Balance ProblemNCT05464004
Effects of Nintendo Wii Balance Board in Children With Cerebral Palsy
A study testing Nintendo Wii balance board in people with Balance Problem and Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
I wan to check the effects of Nintendo Wii balance board therapy in children with CP. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Balance Problem, Cerebral Palsy
- What is being tested?
- Nintendo Wii balance board
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2021to 25 Jun 2022
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with age of 7-14 years. No history of falls. children able to stand independently. delays in gait development.
Who cannot join
- Children with hemiplegic CP. Comorbidities. children with lower limb contractures. hearing disorders. children with epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
I wan to check the effects of Nintendo Wii balance board therapy in children with CP.
Read the detailed description
Evaluate the effects of Nintendo Wii balance board therapy in combination with conventional physical therapy.
- Conditions
- Balance Problem, Cerebral Palsy
- Being tested
- Nintendo Wii balance board
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo Wii balance boardOther
Also called Conventional physical therapy
Experimental group was given Nintendo Wii balance board therapy in combination with conventional physical therapy for 16 sessions/8 weeks
Control group was conventional physical therapy which include stretching of the hamstrings, quadriceps and calf muscles. strengthening of the lower limb. Balance exercises include walk in parallel bar
| Study group | Role | What they receive |
|---|---|---|
| conventional physical therapy | Active comparator | stretching, strengthening and balance exercises Receives: Other: Nintendo Wii balance board |
| Nintendo Wii balance board therapy | Experimental | Nintendo Wii balance board therapy in combination with conventional physical therapy Receives: Other: Nintendo Wii balance board |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Nintendo Wii balance board in children with CP
Changes from the baseline. it was designed to measure the balance issues in children with pediatric balance scale and pediatric forward reach test. it consist of 14 items and total score of 56
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start15 Oct 2021
- Primary completion15 May 2022
- Study completion25 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Balance ProblemStudies 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
- Model description
- Effects of Nintendo Wii balance board in combination with conventional physical therapy in children with CP
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajiha Shahid, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464004
- Sponsor's protocol ID
- REC/RCR & AHS/22/0706
- Status last verified
- Jul 2022
- First submitted
- 14 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
PubMed 17370477Gage JR, Novacheck TF. An update on the treatment of gait problems in cerebral palsy. J Pediatr Orthop B. 2001 Oct;10(4):265-74.
PubMed 11727367Woollacott MH, Shumway-Cook A. Postural dysfunction during standing and walking in children with cerebral palsy: what are the underlying problems and what new therapies might improve balance? Neural Plast. 2005;12(2-3):211-9; discussion 263-72. doi: 10.1155/NP.2005.211.
PubMed 16097489Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
PubMed 32086598
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nintendo Wii Balance Board in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05464004
- Acronym / sponsor ID
- REC/RCR & AHS/22/0706
- Conditions
- Balance Problem, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 19 Jul 2022 (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.
I wan to check the effects of Nintendo Wii balance board therapy in children with CP.
Detailed description
Evaluate the effects of Nintendo Wii balance board therapy in combination with conventional physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Effects of Nintendo Wii balance board in combination with conventional physical therapy in children with CP
| Arm | Type | Receives |
|---|---|---|
| conventional physical therapy | Active comparator | Other: Nintendo Wii balance boardstretching, strengthening and balance exercises |
| Nintendo Wii balance board therapy | Experimental | Other: Nintendo Wii balance boardNintendo Wii balance board therapy in combination with conventional physical therapy |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children with age of 7-14 years. No history of falls. children able to stand independently. delays in gait development.
Key exclusion criteria (1 listed)
- Children with hemiplegic CP. Comorbidities. children with lower limb contractures. hearing disorders. children with 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 |
|---|---|---|
| Nintendo Wii balance boardAlso: Conventional physical therapyExperimental group was given Nintendo Wii balance board therapy in combination with conventional physical therapy for 16 sessions/8 weeks Control group was conventional physical therapy which include stretching of the hamstrings, quadriceps and calf muscles. strengthening of the lower limb. Balance exercises include walk in parallel bar | Other | Nintendo Wii balance board therapy, conventional physical therapy |
Primary outcome
Effects of Nintendo Wii balance board in children with CP
Time frame: 8th week
Changes from the baseline. it was designed to measure the balance issues in children with pediatric balance scale and pediatric forward reach test. it consist of 14 items and total score of 56
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 19 Jul 2022.
- Background: PubMed 17370477Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
- Background: PubMed 11727367Gage JR, Novacheck TF. An update on the treatment of gait problems in cerebral palsy. J Pediatr Orthop B. 2001 Oct;10(4):265-74.
- Background: PubMed 16097489Woollacott MH, Shumway-Cook A. Postural dysfunction during standing and walking in children with cerebral palsy: what are the underlying problems and what new therapies might improve balance? Neural Plast. 2005;12(2-3):211-9; discussion 263-72. doi: 10.1155/NP.2005.211.
- Background: PubMed 32086598Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
- 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.
Wajiha Shahid, MS 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 Nintendo Wii balance board in people with Balance Problem and 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 1 inclusion and 1 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 19 Jul 2022. 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?
Effects of Nintendo Wii balance board in children with CP (time frame: 8th 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 NCT05464004, which also lists 4 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 19 Jul 2022.