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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03755648
Other study ID # 12345
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 20, 2018
Est. completion date October 15, 2018

Study information

Verified date October 2018
Source Ghurki Trust and Teaching Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 15, 2018
Est. primary completion date September 18, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Years to 10 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
traditional physical therapy
Traditional therapy includes hot pack for 15 minutes and stretching for 20 minutes
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.

Locations

Country Name City State
Pakistan Samreen Sadiq Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Ghurki Trust and Teaching Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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