- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03755648
Effect of Delorme Resistance Exercises Versus Treadmill Training in Cerebral Palsy
February 13, 2019 updated by: Samreen Sadiq, Ghurki Trust and Teaching Hospital
Effect of Delorme Resistance Exercises Versus Treadmill Training on Locomotor Abilities in Cerebral Palsy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Samreen Sadiq
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treadmill training
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
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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.
Other Names:
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Other: traditional physical therapy
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
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Traditional therapy includes hot pack for 15 minutes and stretching for 20 minutes
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Experimental: Delorme Resistance exercise
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Locomotor ability
Time Frame: 1 month
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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.
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1 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Hafiz Asim, DPT (USA), Lahore Medical and Dental College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2018
Primary Completion (Actual)
September 18, 2018
Study Completion (Actual)
October 15, 2018
Study Registration Dates
First Submitted
November 9, 2018
First Submitted That Met QC Criteria
November 25, 2018
First Posted (Actual)
November 28, 2018
Study Record Updates
Last Update Posted (Actual)
February 15, 2019
Last Update Submitted That Met QC Criteria
February 13, 2019
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12345 (Danish Center for Healthcare Improvements)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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