Effect of Goal-Oriented GMFM-88 Based Program in Cerebral Palsy.

NCT06709742 | Active Not Recruiting

• 1 other identifier: 8750524INREH
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief Summary

Cerebral Palsy (CP) is a infancy and early childhood disorder that results in motor impairment caused by static and non-progressive lesions in the brain. It has an impact on both the neurological and musculoskeletal systems of the bod. According to the Cerebral Palsy Alliance Research Foundation (CPARF) \& WHO Cerebral Palsy Statistics 2023, approximately 17 million individuals experience some form of CP. This data underscores a notable prevalence rate of 1.5 cases per 1,000 live births within the High-Income Countries (HICs), limited but growing data are obtained from both the Lower Middle-Income Countries (LMICs. The incidence of CP among children in the Swabi district of Khyber Pakhtunkhwa, Pakistan, was 1.22 per 1000 live births. The overall prevalence in Pakistan is still not known, but according to recent documentation, it is estimated to be 4 out of every 1000 live births. The symptoms in CP encompassing atypical muscle contractions, alteration in posture and limitations in movement and physical activity. Furthermore,these symptoms are accompanied by disruptions in sensory perception and cognitive processing along with the challenges of communication, behavioral issues, epileptic seizures and secondary musculoskeletal complications. Motor deficit is present in 65.56% percent of CP cases as well as balance is impaired in most of the cases, and different impairments combinedly decreased overall quality of life (QOL). Because activities of daily living are decreased which in a result increases the caregiver's workload.Despite such a high prevalence of CP, there is still no standardized treatment approach implemented in the clinical settings due to their individualized needs and varying degrees of impairment. Consequently, our study seeks to address this gap by investigating the effect of Goal-Oriented individualized GMFM based programs on enhancing gross motor function, balance and quality of life. By elucidating the potential benefits of intervention, our study aims to contribute to the optimization of therapeutic approaches tailored to the different needs of children with CP.

Conditions

Cerebral Palsy; Quality of Life (QOL); Balance; CP

Keywords

Cerebral Palsy; Gross motor function; Balance; Quality of Life; CP; GMFM-88; BESTest; CP QOL

Outcome Measures

Primary Outcomes (9)

• Gross Motor Function

  The GMFM-88 (Gross Motor Function Measure-88) is a scale used to assess gross motor function in children with CP.

  At Baseline

• Gross Motor Function

  The GMFM-88 (Gross Motor Function Measure-88) is a scale used to assess gross motor function in children with CP.

  Through study completion, at 16th week

• Gross Motor Function

  The GMFM-88 (Gross Motor Function Measure-88) is a scale used to assess gross motor function in children with CP.

  followup of 2 weeks.

• Balance

  The Kids BESTest Scale (Balance Evaluation Systems Test) is used to assess balance in children with CP.

  At Baseline

• Balance

  The Kids BESTest Scale (Balance Evaluation Systems Test) is used to assess balance in children with CP.

  Through study completion, at 16th week

• Balance

  The Kids BESTest Scale (Balance Evaluation Systems Test) is used to assess balance in children with CP.

  followup of 2 weeks.

• Quality Of Life

  The CP QOL (Cerebral Palsy Quality of Life) questionnaire is used to assess the quality of life in children with CP.

  At Baseline

• Quality Of Life

  The CP QOL (Cerebral Palsy Quality of Life) questionnaire is used to assess the quality of life in children with CP.

  Through study completion, at 16th week

• Quality Of Life

  The CP QOL (Cerebral Palsy Quality of Life) questionnaire is used to assess the quality of life in children with CP.

  followup of 2 weeks.

Study Arms (1)

Intervention Group

EXPERIMENTAL

The Intervention based on GMFM-88 items will be given 3 times per week for a duration of 40-45 minutes for each session for 16 weeks.

Other: Gross Motor Function Measure-88 Based Therapy

Interventions

Gross Motor Function Measure-88 Based Therapy OTHER

Children will be assessed initially by using GMFM-88 and selecting specific items for individuals according to his/her needs with the help of experts and family. At least 3 items will be selected for each subject in which they score less such that 0, 1 or 2. Training based on those specific items will be given to the children. This is goal-oriented training in which, according to the needs of children training will be provided.

Also known as: GMFM-88 Based Therapy

Intervention Group

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed Cerebral Palsy,
• Age 5-16 years,
• GMFCS Level I, II \& III,
• Able to understand instructions,
• With/ without any assistive devices.

You may not qualify if:

• CP children with any respiratory disorders,
• Undergoing surgery within the past 6 months,
• Botulinum injection within the last 6 months,
• Unstable seizures,
• Co-existing condition (ADHD, Metabolic Disorder, Progressive disorder),
• Any other co-morbid causing difficulty in performing tasks.

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (2)

ACELP Institute of Child Development

Karachi, Sindh, 07553, Pakistan

Location

Dar-ul-Sukun

Karachi, Sindh, 74200, Pakistan

Location

Related Publications (5)

• Lee M, Ko Y, Shin MM, Lee W. The effects of progressive functional training on lower limb muscle architecture and motor function in children with spastic cerebral palsy. J Phys Ther Sci. 2015 May;27(5):1581-4. doi: 10.1589/jpts.27.1581. Epub 2015 May 26.

  PMID: 26157267 BACKGROUND

• Paul S, Nahar A, Bhagawati M, Kunwar AJ. A Review on Recent Advances of Cerebral Palsy. Oxid Med Cell Longev. 2022 Jul 30;2022:2622310. doi: 10.1155/2022/2622310. eCollection 2022.

  PMID: 35941906 BACKGROUND

• McIntyre S, Goldsmith S, Webb A, Ehlinger V, Hollung SJ, McConnell K, Arnaud C, Smithers-Sheedy H, Oskoui M, Khandaker G, Himmelmann K; Global CP Prevalence Group*. Global prevalence of cerebral palsy: A systematic analysis. Dev Med Child Neurol. 2022 Dec;64(12):1494-1506. doi: 10.1111/dmcn.15346. Epub 2022 Aug 11.

  PMID: 35952356 BACKGROUND

• Cooper MS, Fahey MC, Mackay MT. Making waves: The changing tide of cerebral palsy. J Paediatr Child Health. 2022 Nov;58(11):1929-1934. doi: 10.1111/jpc.16186. Epub 2022 Sep 6.

  PMID: 36066306 BACKGROUND

• Abd-Elfattah HM, Ameen FH, Elkalla RA, Aly SM, Abd-Elrahman NAF. Loaded Functional Strength Training versus Traditional Physical Therapy on Hip and Knee Extensors Strength and Function Walking Capacity in Children with Hemiplegic Cerebral Palsy: Randomized Comparative Study. Children (Basel). 2022 Jun 24;9(7):946. doi: 10.3390/children9070946.

  PMID: 35883930 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr.Amna Aamir Khan, PhD

  Ziauddin College of Physical Therapy, Ziauddin University

  STUDY DIRECTOR

• Ifra Neelum, MPhil

  Ziauddin College of Physical Therapy, Ziauddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 29, 2024
• Study Start: August 15, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)