NCT03755648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2018

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
Last Updated

February 15, 2019

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

November 9, 2018

Last Update Submit

February 13, 2019

Conditions

Keywords

Delorme resistance exercisestreadmill traininglocomotor abilitiestendon of achilles lengthening

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Study Arms (3)

Treadmill training

EXPERIMENTAL

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

traditional physical therapy

OTHER

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

Delorme Resistance exercise

EXPERIMENTAL

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

Interventions

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.

Also known as: traditional physical therapy
Treadmill training

Traditional therapy includes hot pack for 15 minutes and stretching for 20 minutes

traditional physical therapy

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.

Also known as: traditional physical therapy
Delorme Resistance exercise

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samreen Sadiq

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hafiz Asim, DPT (USA)

    Lahore Medical and Dental college

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 28, 2018

Study Start

July 20, 2018

Primary Completion

September 18, 2018

Study Completion

October 15, 2018

Last Updated

February 15, 2019

Record last verified: 2018-10

Locations