Diplegic Cerebral PalsyNCT06460688
Effect of Mother Rehabilitative Aid Education Program on Children With Diplegic Cerebral Palsy
A study testing Mother Rehabilitative Aid Education Program and Neuro physical Therapy in people with Diplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy (CP) is a syndrome caused by a non-progressive lesion in the developing brain. Spastic diplegia cerebral palsy is a form of cerebral palsy, permanently affects muscle control and coordination. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Diplegic Cerebral Palsy
- What is being tested?
- Mother Rehabilitative Aid Education Program and Neuro physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 14 May 2024to 28 Jul 2024
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mothers of spastic cerebral palsy children (Diplegic)
- Mothers of children spastic diplegic CP age 6-12 years either gender
- Mothers of children spastic diplegic CP with GMFCS level II \& III
- Mothers who are willing to spend time in giving home program and give a feedback every day and should maintain continuity coming to the department.
Who cannot join
- Mothers of Cerebral palsy children will be excluded if the children are suffering with fixed deformities.
- Mothers of children having spastic CP with recent surgeries involving spine and limbs
- Working females (>5 hours working time)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Mother Rehabilitative Aid Education Program On Parental Stress And Gross Motor Function Among Children With Diplegic Cerebral Palsy
Cerebral palsy (CP) is a syndrome caused by a non-progressive lesion in the developing brain. Spastic diplegia cerebral palsy is a form of cerebral palsy, permanently affects muscle control and coordination. Symptoms include increased muscle tone which leads to spasticity (stiff or tight muscles and exaggerated reflexes) in the legs. Physiotherapist will come across many children with disability and it's a daily routine that providing treatment and educating parents regarding the treatment and ask them to continue at home. Family centered home program for children with disability plays a major role in their improvement. By educating and creating awareness among mother's, it can really do justice for the recovery of differently abled children.
This will be a randomized control trial. Study will be conducted on 24 patients. Inclusion criteria of this study is mothers of spastic cerebral palsy children (Diplegic), Age 6-12 years, with GMFCS level II \& III and mothers who are willing to spend time in giving home program and give feedback every day and should maintain continuity coming to the department. Mothers of Cerebral palsy (diplegic) children will be excluded if the children are suffering with fixed deformities and with recent surgeries involving spine and limbs. Working females more than 5 working hours are also excluded. Participants will be divided randomly into two groups. In group A, Participants will be educated thoroughly about treatment plan which includes routine neuro physical therapy aiming (Gross Motor Function \& Balance). A class will be organized to educate Mothers/ Caregivers through PPT presentation, video and pictures. In group B, participants will not be educated about treatment plan, routine home plan was given once in a week. Intervention will be given for 8 weeks, 5 days a week for 45 minutes. Pre and post session Gross motor function by GMFM, balance by PBS, Quality of life by CP-QOL and parental stress by PSI will be measured.
Read the detailed description
Participants in group A will be educate thoroughly about treatment plan which includes routine neuro physical therapy aiming (Gross Motor Function \& Balance)which includes (To reduce the spasticity of the muscle by sustained passive stretching of hamstring, tendo-achilles, and adductors (30 secs hold * 3 rep), once a day, five times a week for 8 weeks, Gain trunk control and independent transition by sit to stand facilitation on bolster (5 rep), progressing with single leg sit to stand (5 rep) and multidirectional reach-outs in sitting for five times a week for 8 weeks, train standing and activation of base, Standing training, in which the child was asked to stand while receiving maximum support at the pelvis and knees. After two or more weeks, we began assisting them in taking a few steps with minimal pelvic support. Task oriented approaches were added to facilitate weight shifting for five times a week for 8 weeks, Gain walking with minimal assistance by Gait training with minimal pelvic support assistance. Stepping forward and reach outs for five times a week for 8 weeks. Gain ground clearance and stair climbing by step up and step-down facilitation with stepper and progressing with doing on stair case for 5 times a week for 8 weeks). A class will be organized to educate Mothers/ Caregivers through PPT presentation, video and pictures. This class will contain 3 domains (Counseling, Educating, Practicing). Feedback will be taken on daily basis through video recordings. Mothers will take part in treatment session, 45 minutes for 5 days a week for 8 weeks. In Group B Routine neuro physical therapy will be given for 45 minutes, 5 days a week for 8 weeks. Participants in group B will not be educated about treatment plan. Routine home plan was given in this group once in a week, for 8 weeks.
- Conditions
- Diplegic Cerebral Palsy
- Being tested
- Mother Rehabilitative Aid Education Program, Neuro physical Therapy
- Keywords
- Cerebral Palsy, Gross Motor Function, Mother Rehabilitative Aid, Parental Stress, Spastic Diplegic
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother Rehabilitative Aid Education ProgramOther
Routine neuro physical therapy will be given which includes Stretching, truck control and independent transition, train standing and activation of base, gain walking with minimal assistance, Gain ground clearance with stair climbing. A class will be organized to educate Mothers/ Caregivers through PPT presentation, video and pictures. This class will contain 3 domains (Counseling, Educating, Practicing). Feedback will be taken on daily basis through video recordings. Mothers will take part in treatment session, 45 minutes for 5 days a week for 8 weeks.
Neuro physical TherapyOther
Routine neuro physical therapy will be given which includes Stretching, truck control and independent transition, train standing and activation of base, gain walking with minimal assistance, Gain ground clearance with stair climbing. for 45 minutes, 5 days a week for 8 weeks. Participants in group B will not be educated about treatment plan. Routine home plan was given in this group once in a week, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mother Rehabilitative Aid Education Program | Experimental | Participants in group A will be educate thoroughly about treatment plan which includes routine neuro physical therapy aiming (Gross Motor Function \& Balance) A class will be organized to educate Mothers/ Caregivers through PPT presentation, video and pictures. This class will contain 3 domains (Counseling, Educating, Practicing). Feedback will be taken on daily basis through video recordings. Mothers will take part in treatment session, 45 minutes for 5 days a week for 8 weeks. Receives: Other: Mother Rehabilitative Aid Education Program |
| Neuro physical Therapy. | Active comparator | Routine neuro physical therapy will be given(1) for 45 minutes, 5 days a week for 8 weeks. Participants in group B will not be educated about treatment plan. Routine home plan was given in this group once in a week, for 8 weeks. Receives: Other: Neuro physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMFM-88 (Gross Motor Function Measure)
The Gross Motor Function Measure (GMFM) is a tool that has been developed to assess change in gross motor function in children with cerebral palsy aged 5 months to 16 years of age. The 88 items are grouped into five dimensions: 1) lying and rolling, 2) sitting, 3) crawling and kneeling, 4) standing, and 5) walking, running and jumping. A maximum of three trials is allowed for each item and the best trial is recorded. Scores for each dimension are expressed as a percentage of the maximum score for that dimension and the total score is obtained by averaging the percentage scores across the five dimensions.
Measured: 8 weeks
Parental Stress Index
The degree of parental stress was evaluated with the Parenting Stress Index (PSI) (Abidin and Wilfong 1989). The PSI is designed to identify stressful areas in parent child interactions, and the results from the PSI indicate whether parents experience distress to a clinically disturbing degree. The Parenting Stress Index Short Form was standardized for use with parents of children ranging from 1 month to 12 years old.
Measured: 8 weeks
Secondary outcomes (1)
CP-QOL ( Quality of life)
The CP QOL-Child was designed to assess several aspects of subjective happiness and well-being, rather than ill-being or functioning. It is useful to establish a profile of qualify of life of children with CP to understand their subjective perception of their life (Waters et al., 2009, Waters et al., 2005). Two versions of the CP QOL-Child are available: a primary caregiver-proxy report version (proxy version) for children aged 4-12 years (which we are using), and a self-report version for children aged 9-12 years. The reliability and validity of the CP QOL-Child have been established, including internal consistency, test-retest reliability, and construct validity (Wang et al., 2010, Waters et al., 2007)(19)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start14 May 2024
- Primary completion21 Jul 2024
- Study completion28 Jul 2024
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 Diplegic Cerebral PalsyStudies 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
- It will be Randomized control trial in which non probability convenient sampling will be used. two groups of age 6-12will be formed in which participants will be randomly divided. Group A will receive Mother Rehabilitative Aid Education program with routine neurophysical therapy and Group B will only receive routine neurophysical therapy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Izza Akmal, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460688
- Sponsor's protocol ID
- REC/RCR&AHS/23/07102
- Status last verified
- Aug 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harjpal P, Raipure A, Kovela RK, Qureshi MI. The Effect of Neuro-Physiotherapy on Gross Motor Function in a Male Child With Spastic Diplegic Cerebral Palsy: A Case Report. Cureus. 2022 Sep 19;14(9):e29310. doi: 10.7759/cureus.29310. eCollection 2022 Sep.
PubMed 36277570
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Mother Rehabilitative Aid Education Program On Parental Stress And Gross Motor Function Among Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06460688
- Acronym / sponsor ID
- REC/RCR&AHS/23/07102
- Conditions
- Diplegic Cerebral Palsy
- Keywords
- Cerebral Palsy, Gross Motor Function, Mother Rehabilitative Aid, Parental Stress, Spastic Diplegic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 21 Jul 2024 (actual)
- Study completion
- 28 Jul 2024 (actual)
- First posted
- 14 Jun 2024 (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 (CP) is a syndrome caused by a non-progressive lesion in the developing brain. Spastic diplegia cerebral palsy is a form of cerebral palsy, permanently affects muscle control and coordination. Symptoms include increased muscle tone which leads to spasticity (stiff or tight muscles and exaggerated reflexes) in the legs. Physiotherapist will come across many children with disability and it's a daily routine that providing treatment and educating parents regarding the treatment and ask them to continue at home. Family centered home program for children with disability plays a major role in their improvement. By educating and creating awareness among mother's, it can really do justice for the recovery of differently abled children.
This will be a randomized control trial. Study will be conducted on 24 patients. Inclusion criteria of this study is mothers of spastic cerebral palsy children (Diplegic), Age 6-12 years, with GMFCS level II \& III and mothers who are willing to spend time in giving home program and give feedback every day and should maintain continuity coming to the department. Mothers of Cerebral palsy (diplegic) children will be excluded if the children are suffering with fixed deformities and with recent surgeries involving spine and limbs. Working females more than 5 working hours are also excluded. Participants will be divided randomly into two groups. In group A, Participants will be educated thoroughly about treatment plan which includes routine neuro physical therapy aiming (Gross Motor Function \& Balance). A class will be organized to educate Mothers/ Caregivers through PPT presentation, video and pictures. In group B, participants will not be educated about treatment plan, routine home plan was given once in a week. Intervention will be given for 8 weeks, 5 days a week for 45 minutes. Pre and post session Gross motor function by GMFM, balance by PBS, Quality of life by CP-QOL and parental stress by PSI will be measured.
Detailed description
Participants in group A will be educate thoroughly about treatment plan which includes routine neuro physical therapy aiming (Gross Motor Function \& Balance)which includes (To reduce the spasticity of the muscle by sustained passive stretching of hamstring, tendo-achilles, and adductors (30 secs hold * 3 rep), once a day, five times a week for 8 weeks, Gain trunk control and independent transition by sit to stand facilitation on bolster (5 rep), progressing with single leg sit to stand (5 rep) and multidirectional reach-outs in sitting for five times a week for 8 weeks, train standing and activation of base, Standing training, in which the child was asked to stand while receiving maximum support at the pelvis and knees. After two or more weeks, we began assisting them in taking a few steps with minimal pelvic support. Task oriented approaches were added to facilitate weight shifting for five times a week for 8 weeks, Gain walking with minimal assistance by Gait training with minimal pelvic support assistance. Stepping forward and reach outs for five times a week for 8 weeks. Gain ground clearance and stair climbing by step up and step-down facilitation with stepper and progressing with doing on stair case for 5 times a week for 8 weeks). A class will be organized to educate Mothers/ Caregivers through PPT presentation, video and pictures. This class will contain 3 domains (Counseling, Educating, Practicing). Feedback will be taken on daily basis through video recordings. Mothers will take part in treatment session, 45 minutes for 5 days a week for 8 weeks. In Group B Routine neuro physical therapy will be given for 45 minutes, 5 days a week for 8 weeks. Participants in group B will not be educated about treatment plan. Routine home plan was given in this group once in a week, for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It will be Randomized control trial in which non probability convenient sampling will be used. two groups of age 6-12will be formed in which participants will be randomly divided. Group A will receive Mother Rehabilitative Aid Education program with routine neurophysical therapy and Group B will only receive routine neurophysical therapy
| Arm | Type | Receives |
|---|---|---|
| Mother Rehabilitative Aid Education Program | Experimental | Other: Mother Rehabilitative Aid Education ProgramParticipants in group A will be educate thoroughly about treatment plan which includes routine neuro physical therapy aiming (Gross Motor Function \& Balance) A class will be organized to educate Mothers/ Caregivers through PPT presentation, video and pictures. This class will contain 3 domains (Counseling, Educating, Practicing). Feedback will be taken on daily basis through video recordings. Mothers will take part in treatment session, 45 minutes for 5 days a week for 8 weeks. |
| Neuro physical Therapy. | Active comparator | Other: Neuro physical TherapyRoutine neuro physical therapy will be given(1) for 45 minutes, 5 days a week for 8 weeks. Participants in group B will not be educated about treatment plan. Routine home plan was given in this group once in a week, for 8 weeks. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Mothers of spastic cerebral palsy children (Diplegic)
- Mothers of children spastic diplegic CP age 6-12 years either gender
- Mothers of children spastic diplegic CP with GMFCS level II \& III
- Mothers who are willing to spend time in giving home program and give a feedback every day and should maintain continuity coming to the department.
Key exclusion criteria (3 listed)
- Mothers of Cerebral palsy children will be excluded if the children are suffering with fixed deformities.
- Mothers of children having spastic CP with recent surgeries involving spine and limbs
- Working females (>5 hours working time)
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 |
|---|---|---|
| Mother Rehabilitative Aid Education ProgramRoutine neuro physical therapy will be given which includes Stretching, truck control and independent transition, train standing and activation of base, gain walking with minimal assistance, Gain ground clearance with stair climbing. A class will be organized to educate Mothers/ Caregivers through PPT presentation, video and pictures. This class will contain 3 domains (Counseling, Educating, Practicing). Feedback will be taken on daily basis through video recordings. Mothers will take part in treatment session, 45 minutes for 5 days a week for 8 weeks. | Other | Mother Rehabilitative Aid Education Program |
| Neuro physical TherapyRoutine neuro physical therapy will be given which includes Stretching, truck control and independent transition, train standing and activation of base, gain walking with minimal assistance, Gain ground clearance with stair climbing. for 45 minutes, 5 days a week for 8 weeks. Participants in group B will not be educated about treatment plan. Routine home plan was given in this group once in a week, for 8 weeks. | Other | Neuro physical Therapy. |
Primary outcome
GMFM-88 (Gross Motor Function Measure)
Time frame: 8 weeks
The Gross Motor Function Measure (GMFM) is a tool that has been developed to assess change in gross motor function in children with cerebral palsy aged 5 months to 16 years of age. The 88 items are grouped into five dimensions: 1) lying and rolling, 2) sitting, 3) crawling and kneeling, 4) standing, and 5) walking, running and jumping. A maximum of three trials is allowed for each item and the best trial is recorded. Scores for each dimension are expressed as a percentage of the maximum score for that dimension and the total score is obtained by averaging the percentage scores across the five dimensions.
Parental Stress Index
Time frame: 8 weeks
The degree of parental stress was evaluated with the Parenting Stress Index (PSI) (Abidin and Wilfong 1989). The PSI is designed to identify stressful areas in parent child interactions, and the results from the PSI indicate whether parents experience distress to a clinically disturbing degree. The Parenting Stress Index Short Form was standardized for use with parents of children ranging from 1 month to 12 years old.
1 secondary outcome
CP-QOL ( Quality of life)
Time frame: 8 weeks
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 Aug 2024.
- Background: PubMed 36277570Harjpal P, Raipure A, Kovela RK, Qureshi MI. The Effect of Neuro-Physiotherapy on Gross Motor Function in a Male Child With Spastic Diplegic Cerebral Palsy: A Case Report. Cureus. 2022 Sep 19;14(9):e29310. doi: 10.7759/cureus.29310. eCollection 2022 Sep.
- 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.
Izza Akmal, 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 Mother Rehabilitative Aid Education Program and Neuro physical Therapy in people with Diplegic 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 4 inclusion and 3 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 Aug 2024. 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?
GMFM-88 (Gross Motor Function Measure) (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT06460688, 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 14 Aug 2024.