Comparison Between AOT and Functional Training on Balance, Mobility and Cognition in Diplegic Cerebral Palsy

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05655572
Collaborator
(none)
46
1
2
10
4.6

Study Details

Study Description

Brief Summary

The aim of the study is to find out the effects of Action observation therapy as compared to the traditional physiotherapy in diplegic spastic cerebral palsy patients. We will check the effects on balance mobility and cognition of patients.

Condition or Disease Intervention/Treatment Phase
  • Other: Action Observation Theraoy
  • Other: Functional Training
N/A

Detailed Description

A study conducted in 2020 on diplegic CP patients. The action observation training group repeatedly practiced the action with their motor skills, while the control group practiced conventional physical therapy. Results suggest that action observation training is both feasible and beneficial for improving spasticity, gross motor function, and balance in children with spastic diplegia cerebral palsy.

One of the researcher evaluated the evidence of using Action Observation Therapy in the rehabilitation of children with Cerebral Palsy. It was Systematic review with meta-analysis. No evidence of benefit had been found to draw a firm conclusion regarding the effectiveness of action observation therapy in the rehabilitation of children with cerebral palsy due to limitations in methodological quality and variations between studies.

Some also, investigated the effects of VR-based intervention by means of active videogame on self-concept, balance, motor performance and adaptive success in children with CP. They concluded that VR-based intervention might interfere with the way children with CP perceive themselves, apart from improve their balance, motor performance and adaptive success. Thus VR-based intervention is a potential tool to assist rehabilitation professionals to improve these aspects of children's health condition.

Similarly, A study concluded that Action observation therapy is beneficial in rehabilitation of neurological and musculoskeletal conditions. A study concluded that action observation along with gait training provides greater benefits for gait and cognitive performance in elderly with MCI. According to a scientist action observation therapy is effective and feasible for functional mobility in rehabilitation processes. A researcher in his study action observation therapy is more effective in improving upper limb movements and functions.

There are various studies on movement observation training but most of them are related to restoring the upper limb function of stroke and cerebral palsy patients, and studies on the mobility, cognition, and balance in cerebral palsy for movement observation training are sparse so this study will contribute in examining improvements in rehabilitation of children with diplegic cerebral palsy by demonstrating the effects of action observation training and conventional therapy for the treatment of mobility, cognition, and balance.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison Between Action Observation Therapy and Functional Training on Balance, Mobility and Cognition in Diplegic Cerebral Palsy
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Jan 15, 2023
Anticipated Study Completion Date :
Jan 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Action Observation therapy

This group will perform exercises in stages. First stage consists of movements to improve balance in sitting position with exercises upright the pelvis, move weight forward, move weight to the left and right and rotate right and left. Second stage consist of sit to stand movements with exercises upright the pelvis in sitting position, move weight forward from a sitting position and stand up from a sitting position. Third stage consist of standing movements to improve balance with exercises move weight right and left, forward weight shift with right foot and left foot (lateral view) and forward weight shift with right foot and left foot (front view). Fourth stage consist of walking side ways to left and then towards right. Therapist will perform these tasks and video will be made which will play in front of patients.

Other: Action Observation Theraoy
After initial baseline assessment patients allocated in AOT group will undergo treatment protocol of 6 weeks having 4 stages of duration 1.5 weeks each performed 3 days per week. . Assessment will be perform at baseline after 2, 4 and 6 weeks

Active Comparator: Functional Training Group

participants including in this group will perform the tasks including lying to sitting position, moving in the sitting posture, sitting and standing up, posture training for learning a normal gait pattern, weight bearing and weight movement training in the straight posture, walking training on the flat floor, and stair walking

Other: Functional Training
after baseline assessment participants including in this group will perform the tasks for 6 weeks (3 days per week) s and after that again assessment will be made for examining the improvements.Assessment will be perform at baseline after 2 ,4 and 6 weeks

Outcome Measures

Primary Outcome Measures

  1. Gross motor function measure [6 weeks]

    Changes form the baseline Gross Motor Function measure (GMFM) 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

  2. Pediatric Balance Scale (PBS) [6 weeks]

    Changes from the baseline Pediatric Balance Scale (PBS) 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.

  3. Timed 10 meter walk test [6 weeks]

    Changes from baseline Timed 10 meter walk test 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

  4. Mini-mental state pediatric examination (MMSPE) [6 weeks]

    Changes from baseline Mini-mental state pediatric examination (MMSPE) 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 11 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosed Diaplegic Spastic CP between the age of 5 to 11 years.

  • Able to follow the researcher's instruction.

  • GMFCS (gross motor function classification system) level I-III

  • Children with a modified ashworth scale (MAS) of ≤ 3.

Exclusion Criteria:
  • Unable to walk

  • Children with severe co-morbidities like musculoskeletal deformities, spina bifida and other types of Cerebral Palsy.

  • With visual impairment and visual field defects

Contacts and Locations

Locations

Site City State Country Postal Code
1 Saidu Group of Teaching Hospital Swat Swāt Khyberpakhtunkhuwa Pakistan 25000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Ayesha Bashir, MSNMPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05655572
Other Study ID Numbers:
  • Aizaz Ullah Khan
First Posted:
Dec 19, 2022
Last Update Posted:
Jan 5, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 5, 2023