Effect of Mother Rehabilitative Aid Education Program on Children With Diplegic Cerebral Palsy

Diplegic Cerebral Palsy Clinical Trial

Official title:

Effects Of Mother Rehabilitative Aid Education Program On Parental Stress And Gross Motor Function Among Children With Diplegic Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06460688
• Other study ID #: REC/RCR&AHS/23/07102
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2024
• Est. completion date: July 28, 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: Imran Amjad, PhD
• Phone: 9233224390125
• Email: Imran.amjad[@]ripha.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 28, 2024
• Est. primary completion date: July 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Palsy
• Diplegic Cerebral Palsy
• Paralysis

Intervention

Other:
• Mother Rehabilitative Aid Education Program
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 Therapy
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.

Locations

Country	Name	City	State
Pakistan	Riphah Internationl University	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Primary	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.	8 weeks
Secondary	PBS ( Pediatric Balance Scale)	The PBS is a 14-item, criterion-referenced measure and examines functional balance in the context of everyday tasks. The 14 items that make up the PBS assess many of the functional activities a child must perform to safely and independently function within the home, school, or community: sitting balance, standing balance, sit to stand, stand to sit, transfers, stepping, reaching forward, reaching to the floor, turning, and stepping on and off of an elevated surface. Each item is scored on a 4-point scale. It can be administered and scored in less than 20 minutes using equipment commonly found in schools and clinics. This test has been shown to have good test-retest and interrater reliability when used with school-age children with mild to moderate motor impairment.	8 weeks
Secondary	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)	8 weeks