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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Samreen Sadiq

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Treadmill training
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:
  • traditional physical therapy
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
Other: traditional physical therapy
Traditional therapy includes hot pack for 15 minutes and stretching for 20 minutes
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.
Other: Delorme resistance exercise
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:
  • traditional physical therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Locomotor ability
Time Frame: 1 month
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ghurki Trust and Teaching Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 18, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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