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

NCT06460688 | Completed DMC

• 1 other identifier: REC/RCR&AHS/23/07102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diplegic Cerebral Palsy

Keywords

Cerebral Palsy; Gross Motor Function; Mother Rehabilitative Aid; Parental Stress; Spastic Diplegic

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• CP-QOL ( Quality of life)

  8 weeks

Study Arms (2)

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.

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.

Other: Neuro physical Therapy

Interventions

Mother Rehabilitative Aid Education Program OTHER

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.

Mother Rehabilitative Aid Education Program

Neuro physical Therapy OTHER

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.

Neuro physical Therapy.

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah Internationl University

Lahore, Punjab Province, 54000, Pakistan

Location

Related 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.

  PMID: 36277570 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Izza Akmal, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: May 14, 2024
• Primary Completion: July 21, 2024
• Study Completion: July 28, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)