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Home Versus Hospital Based Action Observation Therapy in Diaplegic Cerebral Palsy

Primary Purpose

Diplegic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Action observation at home
Action Observation therapy at hospital
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diplegic Cerebral Palsy

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Irfan General Hospital Peshawar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Action Observation therapy at home

Action Observation therapy at hospital

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Gross Motor Function measure (GMFM)
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)
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.
Timed 10 meter walk test
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)
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.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2022
Last Updated
February 23, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05586191
Brief Title
Home Versus Hospital Based Action Observation Therapy in Diaplegic Cerebral Palsy
Official Title
Effects of Home Versus Hospital Based Action Observation Therapy on Balance, Mobility and Cognition in Diaplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
February 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diplegic Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Action Observation therapy at home
Arm Type
Experimental
Arm Description
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.
Arm Title
Action Observation therapy at hospital
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Action observation at home
Other Intervention Name(s)
stretching exercises of lower limb
Intervention Description
Exercises included will contain four stages of exercises. Each stage will be followed for 2 weeks i.e. stage 1 for 1st and 2nd week, second stage for 3rd and 4th week, third stage for 5th and 6th week and fourth stage for 7th and 8th week of treatment. Each component of every stage will be played for 1 minute in front of participants, followed by 1 minute rest and then these exercises will be performed for 5 minutes. All participants will perform AOT 3 times/week for up to 8 weeks along with functional training for the rest of the weeks. Functional training will include stretching and isometric exercises (stretching of hamstring and calf muscle while quads isometric). Assessment will be done by using the tools at baseline and after 8 weeks of intervention. A final reading will be taken after 12 weeks to check the maintenance of training effects.
Intervention Type
Other
Intervention Name(s)
Action Observation therapy at hospital
Other Intervention Name(s)
stretching exercises of lower limb
Intervention Description
Exercises included will contain four stages of exercises. Each stage will be followed for 2 weeks i.e. stage 1 for 1st and 2nd week, second stage for 3rd and 4th week, third stage for 5th and 6th week and fourth stage for 7th and 8th week of treatment. Each component of every stage will be played for 1 minute in front of participants, followed by 1 minute rest and then these exercises will be performed for 5 minutes. All participants will perform AOT 3 times/week for up to 8 weeks along with functional training for the rest of the weeks. Functional training will include stretching and isometric exercises (stretching of hamstring and calf muscle while quads isometric). Assessment will be done by using the tools at baseline and after 8 weeks of intervention. A final reading will be taken after 12 weeks to check the maintenance of training effects.
Primary Outcome Measure Information:
Title
Gross Motor Function measure (GMFM)
Description
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)
Time Frame
12 weeks
Title
Pediatric Balance Scale (PBS)
Description
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.
Time Frame
12 weeks
Title
Timed 10 meter walk test
Description
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
Time Frame
12 weeks
Title
Mini-mental state pediatric examination (MMSPE)
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Bashir, MSNMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irfan General Hospital Peshawar
City
Peshawar
State/Province
Khyberpakhtunkhuwa
ZIP/Postal Code
25000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32570855
Citation
Jeong YA, Lee BH. Effect of Action Observation Training on Spasticity, Gross Motor Function, and Balance in Children with Diplegia Cerebral Palsy. Children (Basel). 2020 Jun 18;7(6):64. doi: 10.3390/children7060064.
Results Reference
background
PubMed Identifier
22659636
Citation
Numanoglu A, Gunel MK. Intraobserver reliability of modified Ashworth scale and modified Tardieu scale in the assessment of spasticity in children with cerebral palsy. Acta Orthop Traumatol Turc. 2012;46(3):196-200. doi: 10.3944/aott.2012.2697.
Results Reference
background
PubMed Identifier
24259891
Citation
Kim Y, Lee BH. Clinical Usefulness of Child-centered Task-oriented Training on Balance Ability in Cerebral Palsy. J Phys Ther Sci. 2013 Aug;25(8):947-51. doi: 10.1589/jpts.25.947. Epub 2013 Sep 20.
Results Reference
background
PubMed Identifier
21166669
Citation
Reid SM, Carlin JB, Reddihough DS. Distribution of motor types in cerebral palsy: how do registry data compare? Dev Med Child Neurol. 2011 Mar;53(3):233-8. doi: 10.1111/j.1469-8749.2010.03844.x. Epub 2010 Dec 17.
Results Reference
background
PubMed Identifier
32913838
Citation
Joung HJ, Park J, Ahn J, Park MS, Lee Y. Effects of creative dance-based exercise on gait performance in adolescents with cerebral palsy. J Exerc Rehabil. 2020 Aug 25;16(4):332-343. doi: 10.12965/jer.2040384.192. eCollection 2020 Aug.
Results Reference
background
PubMed Identifier
23346889
Citation
Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24. Erratum In: Dev Med Child Neurol. 2016 Mar;58(3):316.
Results Reference
background
PubMed Identifier
25729163
Citation
Park EC, Hwangbo G. The effects of action observation gait training on the static balance and walking ability of stroke patients. J Phys Ther Sci. 2015 Feb;27(2):341-4. doi: 10.1589/jpts.27.341. Epub 2015 Feb 17.
Results Reference
background
PubMed Identifier
33778479
Citation
Ryan D, Fullen B, Rio E, Segurado R, Stokes D, O'Sullivan C. Effect of Action Observation Therapy in the Rehabilitation of Neurologic and Musculoskeletal Conditions: A Systematic Review. Arch Rehabil Res Clin Transl. 2021 Jan 27;3(1):100106. doi: 10.1016/j.arrct.2021.100106. eCollection 2021 Mar.
Results Reference
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Home Versus Hospital Based Action Observation Therapy in Diaplegic Cerebral Palsy

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