Home Versus Hospital Based Action Observation Therapy in Diaplegic Cerebral Palsy

Not Applicable

Completed

• Conditions: Diplegic Cerebral Palsy
• Interventions: Other: Action observation at home; Other: Action Observation therapy at hospital

• Registration Number: NCT05586191
• Lead Sponsor: Riphah International University

Brief Summary

Effects of Home Versus Hospital Based Action Observation Therapy on Balance, Mobility and Cognition in Diaplegic Cerebral Palsy. It will be a RCT we want to identify the effects of action observation therapy on patients coming to the hospital as compared to the patients at home. We will also identify the retaining effects of AOT. Our sample size will be 40 diplegic patients having no cognitive issues and able to walk with assistive device. We will exclude the patient who will suffer with severe comorbidities and visual impairment. We will randomly assign the patients into two groups A and B.A will receive Action observation therapy three times a day along with stretching exercises .while group B we perform AOT and stretching exercises at home with same frequency.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-20
• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-19
• Status Verified: 2023-02
• Primary Completion: 2023-02-15
• Study Completion: 2023-02-15
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Participants falling in this category will be recruited into the study.

  • Diagnosed Diaplegic CP Children between the age of 5 to 11 years.
  • Without visual impairment and visual field defects.
  • Able to follow the researcher's instruction.
  • GMFCS (gross motor function classification system) level I-III.

Exclusion Criteria

• Participants failing to fall in this category will be excluded of the study.

  • Children with a Modified Ashworth scale (MAS) of 3 or more
  • Unable to walk
  • Children with severe co-morbidities. (2)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Action Observation therapy at home	Action observation at home	In action observation therapy, patient will not come to hospital for treatment. He will see a video at home in which therapist will perform different activities then patient will also perform the same movements.
Action Observation therapy at hospital	Action Observation therapy at hospital	In action observation therapy, patient will come to hospital for treatment. He will see a video in which therapist will perform different activities then patient will also perform the same movements.

Primary Outcome Measures

Name	Time	Method
Timed 10 meter walk test	12 weeks	Changes from Baseline ,It was used to measure the gait ability and speed. The acceleration area 2.5m and deceleration area 2.5m were marked on the ground as start and end point for the test. Participants were asked to walk for 15 minutes on comfortable flat floor at a comfortable speed and then record the walking speed through stopwatch over 10 m between these point. The mean value of the three trials was used and expressed as m/s
Mini-mental state pediatric examination (MMSPE)	12 weeks	Changes from Baseline, it is a cognitive screening task and scoring system for 3 to 14 years old child. It represented 11 questions involving five basic cognitive abilities i.e. attention-concentration, orientation, registration, recall and language and constructive ability.(22) The possible score range is from 0 to 37, from which 17 or lower score indicating as moderate to severe cognitive impairment of children.
Gross Motor Function measure (GMFM)	12 weeks	Changes from baseline,It is the valid and standard observational instrument to measure change in gross motor function in CP children. It consists of 66 items with 5 dimensions. These dimensions are the major motor functions i.e. supine/rolling, sitting, crawling/kneeling, standing and walking/running/jumping. Each task is rated according to the scoring guidelines i.e. higher score indicated better gross motor function. Each GMFM item is graded on 4-point scale i.e. 0 for unable to initiate the task, 1 for able to initiate the task, 2 for able to perform the task partially and 3 for able to perform the task completely. At the end these score summed up into total score.(21)
Pediatric Balance Scale (PBS)	12 weeks	Changes from baseline, It is a modified form of Berg Balance Scale (BSS) which was developed for balance measurement in CP child. It can be performed without specialized equipment and can be easily administered. It including 14 items with 5-level grading to assess the functional activities that child must safely and independently form at home, community, activities including sitting balance, sit to stand/stand to sit, transfer, stepping, reaching forward, reaching to floor, turning and stepping on and off at elevated surface. Each activity is rated according to scale from 0 to 4 i.e. 0 for unable to perform and 4 for able to perform without difficulty.

Trial Locations

Locations (1)

Irfan General Hospital Peshawar; 🇵🇰 Peshawar, Khyberpakhtunkhuwa, Pakistan