Cerebral PalsyNCT05614713
Effect of Sensory Integration Therapy on Balance and Functional Mobility
A study testing Selected physical therapy program and Modified physical therapy program to increase sensory input in people with Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
Purpose: to investigate the effect of sensory integration therapy on balance and functional mobility in children with spastic diplegic cerebral palsy. Methods: children with spastic cerebral palsy, the children were assigned to a control group and a study group. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Selected physical therapy program and Modified physical therapy program to increase sensory input
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 27 Feb 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages from 6-10 years old. The degree of spasticity was 1 to 1+ Level II according to the Gross motor function classification system
Who cannot join
- Visual or auditory problems. Fixed deformities of lower limbs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sensory Integration Therapy on Balance and Functional Mobility in Children With Spastic Cerebral Palsy
Purpose: to investigate the effect of sensory integration therapy on balance and functional mobility in children with spastic diplegic cerebral palsy. Methods: children with spastic cerebral palsy, the children were assigned to a control group and a study group. Balance was assessed using the Biodex balance system and functional mobility was assessed using the Timed Up and Go test.
Read the detailed description
Purpose: to investigate the effect of sensory integration therapy on balance and functional mobility in children with spastic diplegic cerebral palsy. Methods: children with spastic cerebral palsy, the children were assigned to a control group and a study group. Balance was assessed using the Biodex balance system and functional mobility was assessed using the Timed Up and Go test. The control group received selected physical therapy, while the study group received the previously mentioned selected physical therapy program modified to increase sensory input. Treatment sessions for both groups were conducted for both groups for 1 hour once a day, three times per week for two successive months.
- Conditions
- Cerebral Palsy
- Being tested
- Selected physical therapy program, Modified physical therapy program to increase sensory input
- 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 programProcedure or surgery
Gait training and balance training
Modified physical therapy program to increase sensory inputProcedure or surgery
Gait training and balance training using sensory stimulating matts
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | received a modified selected physical therapy program to increase sensory input. Receives: Procedure: Modified physical therapy program to increase sensory input |
| Control group | Active comparator | received a selected physical therapy Receives: Procedure: Selected physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of balance
Assessment by using Biodex Balance System
Measured: After 2 months of intervention
Assessment of functional mobility
Assessment by using the Timed Up and Go test
Measured: After 2 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Sep 2021
- Primary completion1 Feb 2022
- Study completion27 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Model description
- study group and control group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Elsayed Abbass, Cairo University
- Investigators
- Mai E Abbass, Ph.D., Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614713
- Sponsor's protocol ID
- P.T.REC/012/003289
- Status last verified
- Nov 2022
- First submitted
- 6 Nov 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sensory Integration Therapy on Balance and Functional Mobility in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05614713
- Acronym / sponsor ID
- P.T.REC/012/003289
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 27 Feb 2022 (actual)
- First posted
- 14 Nov 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.
Purpose: to investigate the effect of sensory integration therapy on balance and functional mobility in children with spastic diplegic cerebral palsy. Methods: children with spastic cerebral palsy, the children were assigned to a control group and a study group. Balance was assessed using the Biodex balance system and functional mobility was assessed using the Timed Up and Go test.
Detailed description
Purpose: to investigate the effect of sensory integration therapy on balance and functional mobility in children with spastic diplegic cerebral palsy. Methods: children with spastic cerebral palsy, the children were assigned to a control group and a study group. Balance was assessed using the Biodex balance system and functional mobility was assessed using the Timed Up and Go test. The control group received selected physical therapy, while the study group received the previously mentioned selected physical therapy program modified to increase sensory input. Treatment sessions for both groups were conducted for both groups for 1 hour once a day, three times per week for two successive months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- study group and control group
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Modified physical therapy program to increase sensory inputreceived a modified selected physical therapy program to increase sensory input. |
| Control group | Active comparator | Procedure: Selected physical therapy programreceived a selected physical therapy |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Ages from 6-10 years old. The degree of spasticity was 1 to 1+ Level II according to the Gross motor function classification system
Key exclusion criteria (1 listed)
- Visual or auditory problems. Fixed deformities of lower limbs.
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 programGait training and balance training | Procedure or surgery | Control group |
| Modified physical therapy program to increase sensory inputGait training and balance training using sensory stimulating matts | Procedure or surgery | Study group |
Primary outcome
Assessment of balance
Time frame: After 2 months of intervention
Assessment by using Biodex Balance System
Assessment of functional mobility
Time frame: After 2 months of intervention
Assessment by using the Timed Up and Go test
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 14 Nov 2022.
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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.
Mai E Abbass, Ph.D. study director
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 Selected physical therapy program and Modified physical therapy program to increase sensory input in people with Cerebral Palsy, 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 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 14 Nov 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 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?
Assessment of balance (time frame: After 2 months of intervention). 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 14 Nov 2022.