Abstract: Walking disability especially reduction of speed and endurance of walking not only deteriorates walking but also affect on their psycho social health and quality of life. One of the methods has used to improve walking disability in children with cerebral palsy in recent years is walking on treadmill training with or without body weight support. Most of the studies have shown the effect of treadmill training on motor impairments of children with cerebral palsy, however randomized clinical trial studies on adults with cerebral palsy are few. This research will be done three times a week for six weeks. Thirty adults with spastic cerebral palsy will be admitted and randomly will be assigned in two groups. Blindness will perform in patients. In addition, data analysis will have done by statistic consultant. Control group will take routine physiotherapy and intervention group will take routine physiotherapy besides thirty minutes of treadmill training.Walking speed and endurance and Quality of life assessments will be done before treatment, in the 9th session, and after treatment and one month after last session of follow up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014022216680N1
Registration date:2014-09-10, 1393/06/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-10, 1393/06/19
Registrant information
Name
Shohreh Noorizadeh Dehkordi
Name of organization / entity
Iran University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
noorizadeh.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-11-23, 1393/09/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of treadmill training on gait speed, endurance and quality of life in adults with spastic cerebral palsy
Public title
The effects of treadmill training on walking and quality of life in adults with cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are being male or female with age range between 18 to 35 with diagnosis of spastic cerebral palsy, the ability to ambulate with or without an assistive device, and the ability to follow verbal commands. Exclusion criteria are having orthopedic surgery or neurosurgery in the past 12 months, taking anti spastic medications orally or by injection in the past 6 months, having fixed contracture in the lower body joints, having orthopedic or neurologic illness that affects walking, uncontrolled cardiovascular disease or epilepsy.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmmat Expressway, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-07-01, 1393/04/10
Ethics committee reference number
93.105.1582
Health conditions studied
1
Description of health condition studied
Nervous system disease
ICD-10 code
G80.1, G80
ICD-10 code description
Cerebral palsy and other paralytic syndromes
Primary outcomes
1
Description
Walking speed
Timepoint
Exactly before the treatment, in the ninth treatment session, exactly after the treatment and one month after the treatment for follow up
Method of measurement
By using the 10 meter walk test
2
Description
Walking endurance
Timepoint
Exactly before the treatment, in the ninth treatment session, exactly after the treatment and one month after the treatment for follow up
Method of measurement
By using the 6 minute walk test.
3
Description
Quality of life
Timepoint
Exactly before the treatment, in the ninth treatment session, exactly after the treatment and one month after the treatment for follow up
Method of measurement
By using the WHOQOL brief questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The control group will receive routine exercises (including warm up, stretching, and postural control exercises) for 35 minutes.
Category
Rehabilitation
2
Description
The intervention group besides the treatment of control group, will recieve treadmill training for 30 minutes in three sets of 10 minutes with rest interval between sets.