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Effects of TOT on Walking in Children With CP

Sponsor
Riphah International University (Other)
Overall Status
Completed
CT.gov ID
NCT04561349
Collaborator
(none)
44
Enrollment
1
Location
2
Arms
8
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study was to determine the effects of task oriented training (TOT) on walking and balance in children with spastic Cerebral Palsy (CP).

Condition or Disease Intervention/Treatment Phase
  • Other: Task oriented training
  • Other: Conventional rehabilitation treatment
 N/A

Detailed Description

The aim of study is to evaluate the effectiveness of task-oriented training on the walking in Cerebral Palsy children and compare its results with that of the conservative rehabilitation treatment. By training children to walk using task oriented training not only improves their walk and balance but also encourage them to actively participate in their own treatment process. Task oriented training approach can prove to be an effective technique for those CP children who can perform ambulation and have defined targets for gross motor activities

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of Task Oriented Training on Walking in Children With Cerebral Palsy
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Jan 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Task-oriented training (TOT)

Task-oriented training consisted of different functional tasks for lower limbs to improve balance and walk

Other: Task oriented training
Task oriented training consisted of different functional tasks for lower limbs to improve balance and walk. Each task was given 5 minutes Tasks were progressed according to each child's performance. These progressions included increase of repetitions, speed and switching between the tasks. One hour practice of these tasks was advised for home plan
Active Comparator: Conventional rehabilitation treatment

Conventional rehabilitation treatment includes mat activities and range of motion (ROM) of all limbs, Lower limb strengthening and stretching, walking, cycling

Other: Conventional rehabilitation treatment
Conventional rehabilitation treatment includes mat activities and ROM of all limbs, Lower limb strengthening and stretching, walking, cycling. Each exercise was performed for 5 minutes. One hour practice of above exercises and thermotherapy for the spastic muscles advised for 10 minutes once a day at home was advised.

Outcome Measures

Primary Outcome Measures

  1. Timed Up and Go test (TUG) [6th week]

    A line was marked on floor at a distance at a distance of 3 meters (9.8 feet) leveled walking. A score of 30 seconds or more suggests that the person may be prone to falls. Alternatively, a recommended practical cut-off value for the TUG to indicate normal versus below normal performance is 12 seconds.

  2. Functional Walking Test (FWT) [6th week]

    The purpose of function walk test is to evaluate the walking balance and functional walking ability of a child. It has 5 main components. With different scores each, that is 3, 2 and 1. Also it specifies if there is any asymmetry between Right and Left lower limb and better limb functioning is recorded. Total score of FWT is 23 points

  3. Modified Ashworth scale (MAS) [6th week]

    The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform. A score of 1 indicates no resistance, and 5 indicates rigidity.

  4. Gross Motor Function Classification System (GMFCS) [6th week]

    GMFCS divides the CP children into 5 levels, where level 1 is the least affected and most functional children and level 5 most affected and least functional.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Spastic CP children of age between 4 to 14 years

  • With spasticity 2 or less on Modified Ashworth scale

  • Who can walk (GMFCS level 1-3) and can

  • Can perform different activities on command

Exclusion Criteria:

  • Children with cognitive impairment

  • Lower limb surgery in last 6 months

  • Tetraplegic CP and who are unable to walk and follow command

Contacts and Locations

Locations

Site City State Country Postal Code
1 Armed Forces Institute of Rehabilitation Medicine (AFIRM) Rawalpindi Punjab Pakistan

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Nazish Rafique, MSPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT04561349
Other Study ID Numbers:
  • REC/00242 Madiha Tariq
First Posted:
Sep 23, 2020
Last Update Posted:
Sep 23, 2020
Last Verified:
Sep 1, 2020
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
Cerebral Palsy
Walking
Task oriented training
Conventional therapy
Balance
Additional relevant MeSH terms:
Cerebral Palsy

Study Results

No Results Posted as of Sep 23, 2020