Diplegic Cerebral PalsyNCT05348135
Combined Cognitive and Functional Strength Training in Children With cp
A study testing functional strength training, cognitive training and conventional physical therapy in people with Diplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
Cerebral palsy is primarily a disorder of movement and posture however; it often involves disorder of different aspects of cognitive function. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Diplegic Cerebral Palsy
- What is being tested?
- functional strength training, cognitive training and conventional physical therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 11 Mar 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- chronological age ranged from 8 to 12 years,
- spasticity grade in affected lower limbs ranged between 1 + and 2 according to MAS
- can follow instructions given to them,
- their intelligence level ranged from 65 to 80 according to Stanford Binet intelligence scale, - -- their motor function ranged between Level II \& III according to Gross Motor Functional Classification System Expanded and Revised (GMFCS E\&R).
Who cannot join
- children who had visual or auditory problems
- children who took any medicine affecting alertness
- fixed deformities in the joints of upper \& lower limbs
- any orthopedic surgery in lower limbs within 6 months before study
- epileptic children.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synergistic Effect of Functional Strength Training and Cognitive Intervention on Motor and Cognitive Functions in Children With Cerebral Palsy
Cerebral palsy is primarily a disorder of movement and posture however; it often involves disorder of different aspects of cognitive function.
Read the detailed description
This study evaluated the effect of FST and cognitive intervention and their combined effect on motor and cognitive functions in children with spastic diplegia. A convenient sample of spastic diplegic CP children, with their age ranging from 8 to 12 years were assigned randomly into four treatment groups
- Conditions
- Diplegic Cerebral Palsy
- Being tested
- functional strength training, cognitive training, conventional physical therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional strength trainingOther
children in this group received FST. Each training session started with 10 minutes dynamic warm-up period and ended with 5 minutes cool down in the form of muscle stretching and aerobics. The warm up was followed by gait training in addition to 4 functional lower limb exercises; sit to stand exercise, forward/ lateral step-up exercise, half knee rise exercise, and bridging exercise.
cognitive trainingOther
Children in this group received cognitive training by RehaCom cognitive rehabilitation software. Training was applied for four cognitive domains of function; attention / concentration, figural memory, reaction behavior and logical reasoning.
conventional physical therapyOther
including reinforcement of normal motor development, reflex inhibiting patterns, balance exercises, stretching exercises and gait training
| Study group | Role | What they receive |
|---|---|---|
| Functional strength training | Active comparator | Not described Receives: Other: functional strength training |
| Cognitive training | Active comparator | Not described Receives: Other: cognitive training |
| Combined treatment | Active comparator | Not described Receives: Other: functional strength training; Other: cognitive training |
| Conventional physical therapy | Placebo comparator | Not described Receives: Other: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in GMFM-88 measures
criterion-referenced scale that measure gross motor function in children with CP.
Measured: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
change in attention / concentration measures
- Computer based RehaCom software used to assess attention / concentration cognitive domain of function. It is clinically proven and evidence-based software.
- minimum reaction time ( in seconds) of attention / concentration program was assessed
Measured: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
change in figural memory measures
- Computer based RehaCom software used to assess figural memory cognitive domain of function.It is clinically proven and evidence-based software.
- minimum reaction time ( in seconds) of figural memory program was assessed
Measured: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
change in reaction behavior measures
Computer based RehaCom software used to assess reaction behavior cognitive domain of function. It is clinically proven and evidence-based software.
- minimum reaction time ( in seconds) of reaction behavior program was assessed
Measured: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
change in logical reasoning measures
Computer based RehaCom software used to assess logical reasoning cognitive domain of function. It is clinically proven and evidence-based software.
- minimum reaction time ( in seconds) of logical reasoning program was assessed
Measured: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Secondary outcomes (2)
change in Five times sit to stand test (FTSST) measure
measure the time spent for completing five sequential sit to stand to sit cycles. It is a reliable and valid measure of functional muscle strength and balance in CP children.
Measured: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
change in Timed up and go test (TUG)measure
A reliable and valid test used for assessing dynamic balance and functional mobility in the children.
Measured: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 Oct 2020
- Primary completion1 Mar 2022
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diplegic 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Fahmy Hassan Al Nemr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348135
- Sponsor's protocol ID
- No:P.T.REC/012/003398
- Status last verified
- Apr 2022
- First submitted
- 12 Mar 2022
- Last updated
- 27 Apr 2022
- 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 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effect of Functional Strength Training and Cognitive Intervention on Motor and Cognitive Functions in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05348135
- Acronym / sponsor ID
- No:P.T.REC/012/003398
- Conditions
- Diplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 27 Apr 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.
Cerebral palsy is primarily a disorder of movement and posture however; it often involves disorder of different aspects of cognitive function.
Detailed description
This study evaluated the effect of FST and cognitive intervention and their combined effect on motor and cognitive functions in children with spastic diplegia. A convenient sample of spastic diplegic CP children, with their age ranging from 8 to 12 years were assigned randomly into four treatment groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Functional strength training | Active comparator | Other: functional strength training |
| Cognitive training | Active comparator | Other: cognitive training |
| Combined treatment | Active comparator | Other: functional strength training, Other: cognitive training |
| Conventional physical therapy | Placebo comparator | Other: conventional physical therapy |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- chronological age ranged from 8 to 12 years,
- spasticity grade in affected lower limbs ranged between 1 + and 2 according to MAS
- can follow instructions given to them,
- their intelligence level ranged from 65 to 80 according to Stanford Binet intelligence scale, - -- their motor function ranged between Level II \& III according to Gross Motor Functional Classification System Expanded and Revised (GMFCS E\&R).
Key exclusion criteria (5 listed)
- children who had visual or auditory problems
- children who took any medicine affecting alertness
- fixed deformities in the joints of upper \& lower limbs
- any orthopedic surgery in lower limbs within 6 months before study
- epileptic children.
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 |
|---|---|---|
| functional strength trainingchildren in this group received FST. Each training session started with 10 minutes dynamic warm-up period and ended with 5 minutes cool down in the form of muscle stretching and aerobics. The warm up was followed by gait training in addition to 4 functional lower limb exercises; sit to stand exercise, forward/ lateral step-up exercise, half knee rise exercise, and bridging exercise. | Other | Combined treatment, Functional strength training |
| cognitive trainingChildren in this group received cognitive training by RehaCom cognitive rehabilitation software. Training was applied for four cognitive domains of function; attention / concentration, figural memory, reaction behavior and logical reasoning. | Other | Cognitive training, Combined treatment |
| conventional physical therapyincluding reinforcement of normal motor development, reflex inhibiting patterns, balance exercises, stretching exercises and gait training | Other | Conventional physical therapy |
Primary outcome
change in GMFM-88 measures
Time frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
criterion-referenced scale that measure gross motor function in children with CP.
change in attention / concentration measures
Time frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
* Computer based RehaCom software used to assess attention / concentration cognitive domain of function. It is clinically proven and evidence-based software. * minimum reaction time ( in seconds) of attention / concentration program was assessed
change in figural memory measures
Time frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
* Computer based RehaCom software used to assess figural memory cognitive domain of function.It is clinically proven and evidence-based software. * minimum reaction time ( in seconds) of figural memory program was assessed
change in reaction behavior measures
Time frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Computer based RehaCom software used to assess reaction behavior cognitive domain of function. It is clinically proven and evidence-based software. - minimum reaction time ( in seconds) of reaction behavior program was assessed
change in logical reasoning measures
Time frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
Computer based RehaCom software used to assess logical reasoning cognitive domain of function. It is clinically proven and evidence-based software. - minimum reaction time ( in seconds) of logical reasoning program was assessed
2 secondary outcomes
change in Five times sit to stand test (FTSST) measure
Time frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
change in Timed up and go test (TUG)measure
Time frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up
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 27 Apr 2022.
- Individual participant dataSharing planned: No
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Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional strength training, cognitive training and conventional physical therapy in people with Diplegic 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 4 inclusion and 5 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 27 Apr 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. Some participants in this study may receive a placebo. 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?
change in GMFM-88 measures (time frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up). The study lists 5 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 27 Apr 2022.