Clinical trial NCT06460688: Effect of Mother Rehabilitative Aid Education Program on Children With Diplegic Cerebral Palsy
Official title: Effects Of Mother Rehabilitative Aid Education Program On Parental Stress And Gross Motor Function Among Children With Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diplegic Cerebral Palsy
Keywords: Cerebral Palsy
Gross Motor Function
Mother Rehabilitative Aid
Parental Stress
Spastic Diplegic
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: GMFM-88 (Gross Motor Function Measure)
timeFrame: 8 weeks
measure: Parental Stress Index
timeFrame: 8 weeks
Secondary outcomes:
measure: CP-QOL ( Quality of life)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah Internationl University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Izza Akmal, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.