Cerebral PalsyNCT04533789
Virtual Reality versusTask-oriented for Gait in CP
A study testing selected physical therapy program in people with Cerebral Palsy, run by South Valley University at 1 site in Egypt.
Trial summary
The children with hemiplegic cerebral palsy had a longer gait cycle, slower walking speed, and longer support phase than did the healthy children. The support phase was longer than the swing phase in the children with hemiplegic cerebral palsy Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- selected physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 22 May 2019to 29 Jul 2020
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their age will ranging from 7 to 9 years.
- Children participated in this study will from both sexes.
- Their degree of spasticity will ranged from mild to moderate according to Modified Ashworth Scale.
- All children will able to walk supported or unsupported by the therapist.
- Children will able to follow the instructions during testing and training.
- All children had no fixed contractures or deformities at the lower limb.
Who cannot join
- Children with visual or auditory problems.
- Children with history of epilepsy.
- Children with structural joints deformities of the lower limbs.
- Children with history of surgical interference in lower limbs less than one year.
- Children with convulsions and fixed contractures.
- Uncooperative children.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wii Sport Games Versus Task-oriented Training on Gait in Children With Unilateral Cerebral Palsy
The children with hemiplegic cerebral palsy had a longer gait cycle, slower walking speed, and longer support phase than did the healthy children. The support phase was longer than the swing phase in the children with hemiplegic cerebral palsy
Read the detailed description
This research aims to evaluate the effect of virtual reality (VR) games on balance recovery of children with cerebral palsy (CP) by quantitatively synthesizing the existing literature, and to further determine the impact of VR game intervention (the duration of each intervention, intervention frequency, intervention cycle, and total intervention time) on the balance recovery of children with CP.
A high-intensity task-oriented training programme designed to improve hemiplegic gait and physical fitness was feasible in the present study and the effectiveness exceeds a low intensity physiotherapy-programme in terms of gait speed and walking capacity in hemiplegic cp. In a future study, seems appropriate to additionally use measures to evaluate physical fitness and energy expenditure while walking.
- Conditions
- Cerebral Palsy
- Being tested
- selected physical therapy program
- Keywords
- wii sport, task oriented training, hemiplegic cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selected physical therapy programOther
strengthening muscles of upper and lower limbs, balancing exercise, gait training in open environment, stretching for elbow flexors and forearm pronators,lower limb hip flexors and knee extensor and ankle dorsiflexors
| Study group | Role | What they receive |
|---|---|---|
| the control group | Experimental | Group 1 the control group received selected physical therapy program which contain strengthening exercises for upper limb and lower limb muscles, stretching exercises for elbow extensors, hand supinator, wrist extensors, knee extensors and ankle dorsiflexors, balancing exercises, coordination exercises and gait training exercises in open environment. Receives: Other: selected physical therapy program |
| virtual reality | Experimental | Group 2 the study group received the same physical therapy program 30 min. plus virtual reality for 30 min. Receives: Other: selected physical therapy program |
| Task oriented | Experimental | Group 3 the study group received the same physical therapy program 30 min. plus task oriented training for 30 min. Receives: Other: selected physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
cadence (number)
number of steps in each min.
Measured: cadence assessed at day 0.
cadence (number)
number of steps in each min.
Measured: cadence assessed at day 90.
step length of affected side (cm)
distance between the point of initial contact of one foot and the point of initial contact of the opposite foot (cm)
Measured: step length assessed at day 0.
step length of affected side (cm)
distance between the point of initial contact of one foot and the point of initial contact of the opposite foot (cm)
Measured: step length assessed at day 90.
stride length of affected side(cm)
the distance from the toe of right foot (starting position) to the toe of right foot (ending position), or the heel of right foot (starting position) to the heel of right foot (ending position). (cm)
Measured: stride length assessed at day 0.
stride length of affected side(cm)
the distance from the toe of right foot (starting position) to the toe of right foot (ending position), or the heel of right foot (starting position) to the heel of right foot (ending position). (cm)
Measured: stride length assessed at day 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start22 May 2019
- Primary completion22 May 2020
- Study completion29 Jul 2020
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 Cerebral PalsyStudies of the same condition, open and under way.
- 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
- G 1 (control) received traditional physical therapy program for 60 min. G 2 (study) received traditional physical therapy program for 30 min. and virtual reality for 30 min. G 3 (study) received traditional physical therapy program for 30 min. and task oriented training for 30 min. all groups treated for four successive months.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehad Ahmed Youness Abo-zaid, South Valley University
- Investigators
- Mohammed E Ali, PhD student, Principal investigator, South Valley University, Faculty of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533789
- Sponsor's protocol ID
- P.T.REC/012/001729
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Wang Y. Gait analysis of children with spastic hemiplegic cerebral palsy. Neural Regen Res. 2012 Jul 15;7(20):1578-84. doi: 10.3969/j.issn.1673-5374.2012.20.008.
PubMed 25657696Patterson KK, Gage WH, Brooks D, Black SE, McIlroy WE. Evaluation of gait symmetry after stroke: a comparison of current methods and recommendations for standardization. Gait Posture. 2010 Feb;31(2):241-6. doi: 10.1016/j.gaitpost.2009.10.014. Epub 2009 Nov 22.
PubMed 19932621Grasso R, Assaiante C, Prevost P, Berthoz A. Development of anticipatory orienting strategies during locomotor tasks in children. Neurosci Biobehav Rev. 1998 Jul;22(4):533-9. doi: 10.1016/s0149-7634(97)00041-9.
PubMed 9595566Gatica-Rojas V, Mendez-Rebolledo G, Guzman-Munoz E, Soto-Poblete A, Cartes-Velasquez R, Elgueta-Cancino E, Cofre Lizama LE. Does Nintendo Wii Balance Board improve standing balance? A randomized controlled trial in children with cerebral palsy. Eur J Phys Rehabil Med. 2017 Aug;53(4):535-544. doi: 10.23736/S1973-9087.16.04447-6. Epub 2016 Nov 24.
PubMed 27882910
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wii Sport Games Versus Task-oriented Training on Gait in Children With Unilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04533789
- Acronym / sponsor ID
- P.T.REC/012/001729
- Conditions
- Cerebral Palsy
- Keywords
- wii sport, task oriented training, hemiplegic cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 29 Jul 2020 (actual)
- First posted
- 1 Sep 2020 (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 children with hemiplegic cerebral palsy had a longer gait cycle, slower walking speed, and longer support phase than did the healthy children. The support phase was longer than the swing phase in the children with hemiplegic cerebral palsy
Detailed description
This research aims to evaluate the effect of virtual reality (VR) games on balance recovery of children with cerebral palsy (CP) by quantitatively synthesizing the existing literature, and to further determine the impact of VR game intervention (the duration of each intervention, intervention frequency, intervention cycle, and total intervention time) on the balance recovery of children with CP.
A high-intensity task-oriented training programme designed to improve hemiplegic gait and physical fitness was feasible in the present study and the effectiveness exceeds a low intensity physiotherapy-programme in terms of gait speed and walking capacity in hemiplegic cp. In a future study, seems appropriate to additionally use measures to evaluate physical fitness and energy expenditure while walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- G 1 (control) received traditional physical therapy program for 60 min. G 2 (study) received traditional physical therapy program for 30 min. and virtual reality for 30 min. G 3 (study) received traditional physical therapy program for 30 min. and task oriented training for 30 min. all groups treated for four successive months.
| Arm | Type | Receives |
|---|---|---|
| the control group | Experimental | Other: selected physical therapy programGroup 1 the control group received selected physical therapy program which contain strengthening exercises for upper limb and lower limb muscles, stretching exercises for elbow extensors, hand supinator, wrist extensors, knee extensors and ankle dorsiflexors, balancing exercises, coordination exercises and gait training exercises in open environment. |
| virtual reality | Experimental | Other: selected physical therapy programGroup 2 the study group received the same physical therapy program 30 min. plus virtual reality for 30 min. |
| Task oriented | Experimental | Other: selected physical therapy programGroup 3 the study group received the same physical therapy program 30 min. plus task oriented training for 30 min. |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Their age will ranging from 7 to 9 years.
- Children participated in this study will from both sexes.
- Their degree of spasticity will ranged from mild to moderate according to Modified Ashworth Scale.
- All children will able to walk supported or unsupported by the therapist.
- Children will able to follow the instructions during testing and training.
Key exclusion criteria (6 listed)
- Children with visual or auditory problems.
- Children with history of epilepsy.
- Children with structural joints deformities of the lower limbs.
- Children with history of surgical interference in lower limbs less than one year.
- Children with convulsions and fixed contractures.
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 |
|---|---|---|
| selected physical therapy programstrengthening muscles of upper and lower limbs, balancing exercise, gait training in open environment, stretching for elbow flexors and forearm pronators,lower limb hip flexors and knee extensor and ankle dorsiflexors | Other | Task oriented, the control group, virtual reality |
Primary outcome
cadence (number)
Time frame: cadence assessed at day 0.
number of steps in each min.
cadence (number)
Time frame: cadence assessed at day 90.
number of steps in each min.
step length of affected side (cm)
Time frame: step length assessed at day 0.
distance between the point of initial contact of one foot and the point of initial contact of the opposite foot (cm)
step length of affected side (cm)
Time frame: step length assessed at day 90.
distance between the point of initial contact of one foot and the point of initial contact of the opposite foot (cm)
stride length of affected side(cm)
Time frame: stride length assessed at day 0.
the distance from the toe of right foot (starting position) to the toe of right foot (ending position), or the heel of right foot (starting position) to the heel of right foot (ending position). (cm)
stride length of affected side(cm)
Time frame: stride length assessed at day 90.
the distance from the toe of right foot (starting position) to the toe of right foot (ending position), or the heel of right foot (starting position) to the heel of right foot (ending position). (cm)
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 1 Sep 2020.
- Background: PubMed 25657696Wang X, Wang Y. Gait analysis of children with spastic hemiplegic cerebral palsy. Neural Regen Res. 2012 Jul 15;7(20):1578-84. doi: 10.3969/j.issn.1673-5374.2012.20.008.
- Background: PubMed 19932621Patterson KK, Gage WH, Brooks D, Black SE, McIlroy WE. Evaluation of gait symmetry after stroke: a comparison of current methods and recommendations for standardization. Gait Posture. 2010 Feb;31(2):241-6. doi: 10.1016/j.gaitpost.2009.10.014. Epub 2009 Nov 22.
- Background: PubMed 9595566Grasso R, Assaiante C, Prevost P, Berthoz A. Development of anticipatory orienting strategies during locomotor tasks in children. Neurosci Biobehav Rev. 1998 Jul;22(4):533-9. doi: 10.1016/s0149-7634(97)00041-9.
- Results publication: PubMed 27882910Gatica-Rojas V, Mendez-Rebolledo G, Guzman-Munoz E, Soto-Poblete A, Cartes-Velasquez R, Elgueta-Cancino E, Cofre Lizama LE. Does Nintendo Wii Balance Board improve standing balance? A randomized controlled trial in children with cerebral palsy. Eur J Phys Rehabil Med. 2017 Aug;53(4):535-544. doi: 10.23736/S1973-9087.16.04447-6. Epub 2016 Nov 24.
- 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.
Mohammed E Ali, PhD student principal investigator
South Valley University, Faculty of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selected physical therapy program in people with Cerebral Palsy, run by South Valley 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 6 inclusion and 6 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 1 Sep 2020. 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?
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?
cadence (number) (time frame: cadence assessed at day 0.). The study lists 6 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 NCT04533789, 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 1 Sep 2020.