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Effect of Delorme Resistance Exercises Versus Treadmill Training in Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Treadmill training
traditional physical therapy
Delorme resistance exercise
Sponsored by
Ghurki Trust and Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Delorme resistance exercises, treadmill training, locomotor abilities, tendon of achilles lengthening

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children with Gross Motor Functional Scale Level II and III
  • Ability to understand commands and directions
  • Diplegic type of cerebral palsy
  • Children who had undergone bilateral Tendon of Achilles Lengthening procedure 3 to 6 months post-operatively

Exclusion Criteria:

  • Children presenting with other types of Cerebral Palsy
  • Children with audiovisual impairment that can hinder the treatment
  • leg length discrepancy greater than 2 cm,
  • Fixed contractures, joint instability and associated cardiovascular condition.

Sites / Locations

  • Samreen Sadiq

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Experimental

Arm Label

Treadmill training

traditional physical therapy

Delorme Resistance exercise

Arm Description

Group A: received treadmill training along with traditional physiotherapy.. The motorized treadmill was used keeping treatment parameters as 50 Hertz, 10 Ampere and 220 Volts The treadmill training was provided by giving instructions first and then warm up was given for 5 minutes prior to the training. The children were upright with the feet flat on treadmill platform. The height of handrails was adjustable according to every child thus keeping their gaze forward. The training was ended at cool down period of 5 minutes

Traditional therapy includes use of hot packs for 15 minutes and stretching for 20 minutes which will be applied to both groups prior to actual intervention

Group B received delorme resistance exercise with traditional physiotherapy. Delorme Resistance Training was also initiated with 5 minute warm up period. It was started with 10 Repetition Maximum and was gradually increased. The treatment session was thirty minutes for each group, six times a week for three months.

Outcomes

Primary Outcome Measures

Locomotor ability
Locomotor ability was assessed using ABILOCO-kids questionnaire. It consisted of 10 locomotion activities of which difficulty was rated by the parents. It has good reliability r=0.97 and reproducibility of 0.96. Parent is asked to fill in questionnaire by estimating their child's ease or difficulty in performing each activity. Activities are presented in 10 different random orders to avoid any systematic effect. During evaluation, 3-level response scale is presented to parent. Parent is asked to rate his perception on response scale as 'Impossible', 'Difficult' or 'Easy'. Activities not attempted by child within last 3 months are not scored and are entered as not applicable. Activities that child doesn't perform because they are too difficult must be scored as 'Impossible'. Child's locomotion ability and its 95% confidence interval are located on locomotion ability scale expressed in logits. Higher the ability of a child the more the measure will be located to the right.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2018
Last Updated
February 13, 2019
Sponsor
Ghurki Trust and Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03755648
Brief Title
Effect of Delorme Resistance Exercises Versus Treadmill Training in Cerebral Palsy
Official Title
Effect of Delorme Resistance Exercises Versus Treadmill Training on Locomotor Abilities in Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
September 18, 2018 (Actual)
Study Completion Date
October 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ghurki Trust and Teaching Hospital

4. Oversight

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

5. Study Description

Brief Summary
Cerebral palsy is one of the most important source of disability among children and its incidence is almost 3.6 in thousand live births.Children with Cerebral Palsy presents with ambulatory difficulties.The current study highlights the effect of treadmill training as compared to DeLorme resistance exercises on locomotor activities in cerebral palsy child.The present study would add to the clinical knowledge of physical therapists by promoting the implementation of treadmill training and DeLorme resistance exercises for this prevalent pediatric neurodevelopmental disorder. The study would decrease the burden of disease among community and enhance the social participation of cerebral palsy children. This in turn would improve the quality of living of these disabling diseased children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Delorme resistance exercises, treadmill training, locomotor abilities, tendon of achilles lengthening

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treadmill training
Arm Type
Experimental
Arm Description
Group A: received treadmill training along with traditional physiotherapy.. The motorized treadmill was used keeping treatment parameters as 50 Hertz, 10 Ampere and 220 Volts The treadmill training was provided by giving instructions first and then warm up was given for 5 minutes prior to the training. The children were upright with the feet flat on treadmill platform. The height of handrails was adjustable according to every child thus keeping their gaze forward. The training was ended at cool down period of 5 minutes
Arm Title
traditional physical therapy
Arm Type
Other
Arm Description
Traditional therapy includes use of hot packs for 15 minutes and stretching for 20 minutes which will be applied to both groups prior to actual intervention
Arm Title
Delorme Resistance exercise
Arm Type
Experimental
Arm Description
Group B received delorme resistance exercise with traditional physiotherapy. Delorme Resistance Training was also initiated with 5 minute warm up period. It was started with 10 Repetition Maximum and was gradually increased. The treatment session was thirty minutes for each group, six times a week for three months.
Intervention Type
Other
Intervention Name(s)
Treadmill training
Other Intervention Name(s)
traditional physical therapy
Intervention Description
The motorized treadmill treatment parameters considered will be 50 Hertz, 10 Ampere and 220 Volts. The speed of treadmill will be controlled with a single finger tip allowing an individual to exercise in safe environment with sufficient space.The treadmill training will be provided by giving instructions first and then warm up will be given for 5 minutes prior to the training. The children will be upright with the feet flat on treadmill platform. The height of handrails will be adjustable according to every child thus keeping their gaze forward. The training will be ended at cool down period of 5 minutes.The treatment session will be thirty minutes for each group, six times a week for three months.
Intervention Type
Other
Intervention Name(s)
traditional physical therapy
Intervention Description
Traditional therapy includes hot pack for 15 minutes and stretching for 20 minutes
Intervention Type
Other
Intervention Name(s)
Delorme resistance exercise
Other Intervention Name(s)
traditional physical therapy
Intervention Description
Delorme Resistance Training was also initiated with 5 minute warm up period. It was started with 10 Repetition Maximum and was gradually increased. The treatment session was thirty minutes for each group, six times a week for three months.
Primary Outcome Measure Information:
Title
Locomotor ability
Description
Locomotor ability was assessed using ABILOCO-kids questionnaire. It consisted of 10 locomotion activities of which difficulty was rated by the parents. It has good reliability r=0.97 and reproducibility of 0.96. Parent is asked to fill in questionnaire by estimating their child's ease or difficulty in performing each activity. Activities are presented in 10 different random orders to avoid any systematic effect. During evaluation, 3-level response scale is presented to parent. Parent is asked to rate his perception on response scale as 'Impossible', 'Difficult' or 'Easy'. Activities not attempted by child within last 3 months are not scored and are entered as not applicable. Activities that child doesn't perform because they are too difficult must be scored as 'Impossible'. Child's locomotion ability and its 95% confidence interval are located on locomotion ability scale expressed in logits. Higher the ability of a child the more the measure will be located to the right.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with Gross Motor Functional Scale Level II and III Ability to understand commands and directions Diplegic type of cerebral palsy Children who had undergone bilateral Tendon of Achilles Lengthening procedure 3 to 6 months post-operatively Exclusion Criteria: Children presenting with other types of Cerebral Palsy Children with audiovisual impairment that can hinder the treatment leg length discrepancy greater than 2 cm, Fixed contractures, joint instability and associated cardiovascular condition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiz Asim, DPT (USA)
Organizational Affiliation
Lahore Medical and Dental college
Official's Role
Study Chair
Facility Information:
Facility Name
Samreen Sadiq
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

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Effect of Delorme Resistance Exercises Versus Treadmill Training in Cerebral Palsy

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