Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 31 of 10381 for:    strength

Progressive Functional Strength Training in Unilateral Spastic Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02460406
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Ozgun Kaya Kara, Hacettepe University

Brief Summary:
This study is aimed to investigate effectiveness of progressive functional strength training protocol (functional squat system with virtual reality in leg press, plyometric exercises, exercises with Bosu ball & heel-rise exercises) on Body Functions and activity in children with unilateral spastic Cerebral Palsy (CP) by applying current guidelines. According to literature, there are studies that investigate the effects of functional strength training in children with CP. But there is no randomized controlled trial, explore the effects of progressive functional strength training protocol on body functions and activity on unilateral spastic CP. Hypothesis of this study is that progressive functional strength training protocol improves performance-related physical fitness, gross motor function, dynamic, balance, muscle tone and muscle strength in unilateral spastic CP.

Condition or disease Intervention/treatment Phase
Spastic Hemiplegic Cerebral Palsy Other: traditional physiotherapy Other: progressive functional strength training Not Applicable

Detailed Description:
Cerebral palsy (CP) describes a group of disorders in the development of movement and posture, causing activity limitations, which are attributed to non-progressive disturbances that occurred in the developing brain. It is the most common cause of movement disability in childhood. Children with CP may experience a variety of impaired muscle functions, such as spasticity, muscle weakness, and loss of selective motor control. Muscle structural changes are caused to activate of mechanisms that are limited function with growing and maturation. The weakness found in children with CP is attributable to both altered neural mechanisms and muscle tissue changes. Several factors affect the level of weakness found in the muscles of children with CP. First, weakness may differ between proximal and distal limb muscles. Stackhouse et al. found that the maximum voluntary contraction (MVC) was more impaired in the plantar flexors than the quadriceps of children with mild CP compared with controls. Second, the peak torque may vary according to the velocity of limb movement. Peak torque of the knee flexors and extensors in 24 children with CP was found to decrease with increasing velocity on an isokinetic machine. Third, peak torque may vary according to muscle length. An isokinetic study of 44 children and young people with CP found that peak torque in the hip abductors occurred when the muscle was in a lengthened position with the leg still in adduction. Fourth, the type of contraction was found to consistently affect the peak torque in both children with CP and those who are typically developing, with eccentric force being greater than concentric force in the same muscle. Although all impaired muscle functions limit the performance of daily life activities and participation in a child with CP, a recent study has shown that muscle weakness showed a stronger association with mobility limitations in children with CP than spasticity. Strength training for these children is, therefore, expected to improve or maintain their strength and functional performance.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Lower Limb Progressive Functional Strength Training Protocol on Body Functions and Activity in Children With Unilateral Spastic Cerebral Palsy: a Single-blind Randomized Controlled Trial
Study Start Date : September 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
control group
traditional physiotherapy (stretching, normal range of movement, walking)
Other: traditional physiotherapy
We are applying routine traditional physiotherapy consisted of neurodevelopmental treatment (stretching, weight bearing, functional reaching & walking so on).

Active Comparator: intervention group
progressive functional strength training protocol on lower extremities consisted of functional squat system with virtual reality in leg press, plyometric exercises, exercises with Bosu ball & heel-rise exercises.
Other: progressive functional strength training
Participants allocated to the experimental group completed three times a week, 12-week progressive resistance training protocol. This protocol consisted of functional squat system with virtual reality in leg press, plyometric exercises, exercises with Bosu ball & heel-rise exercises. This intensity of training is approximately equal to training at an intensity of 60% to 80% of one-repetition maximum according to "National Strength and Conditioning Association (NSCA)" protocols. Intensity of exercise is gradually increased 10% bi-weekly.




Primary Outcome Measures :
  1. muscle strength [ Time Frame: change from basaline muscle strenght of lower extremities at 12 weeks ]
    8 channels Biopac® surface electromyography data acquisition and analysis systems for root mean square of maximum voluntary contraction, hand-held dynamometer "Power track II commander" for isometric muscle strength and functional squat rehabilitation system with leg press for one-maximum repetition was used to evaluate muscle strength.


Secondary Outcome Measures :
  1. gross motor function [ Time Frame: change from basaline gross motor funciton at 12 weeks ]
    Gross motor function will be assessed using dimensions D and E of the Gross Motor Function Measurement (GMFM), which consists of standing, and walking, running, and jumping. 10-metre walking and 1-minute walking will be evaluated function.

  2. muscle tone [ Time Frame: change from basaline muscle tone at 12 weeks ]
    modified Tardieu scale was used to evaluate muscle tone.

  3. balance [ Time Frame: change from basaline balance at 12 week ]
    Dynamic balance was assessed with Time up & go and functional reaching test.

  4. functional muscle strength [ Time Frame: change from basaline funcitonal muscle strenght at 12 weeks ]
    The 30s Repetition Maximum test was used to assess functional muscle strength of the lower extremities. The three closed kinetic chain exercises of lateral step-up test, sit to stand, and attain stand through half knee were used.

  5. muscle performance [ Time Frame: change from basaline muscle performance at 12 weeks ]
    Standing Broad Jump and vertical jump was used to evaluate muscle performance.

  6. power [ Time Frame: change from basaline short-term muscle power at 12 weeks ]
    Short-term muscle power was evaluated using the mean power and peak power obtained from the Muscle Power Sprint Test.

  7. Agility [ Time Frame: change from basaline agility at 12 weeks ]
    Agility was measured via using the 10x5m sprint test.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 7 years and 16 years;
  • classified in levels I of the Gross Motor Function Classification System (GMFCS)
  • able to follow and accept verbal instructions

Exclusion Criteria:

  • any orthopaedic surgery or botulinum toxin injection in the past 6 months,
  • children whose parents refused to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460406


Locations
Layout table for location information
Turkey
Hacettepe University
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Investigators
Layout table for investigator information
Study Director: Ozgun Kaya Kara, PhD Hacettepe University

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Ozgun Kaya Kara, PT, PhD, Hacettepe University
ClinicalTrials.gov Identifier: NCT02460406     History of Changes
Other Study ID Numbers: GO 14/224
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ozgun Kaya Kara, Hacettepe University:
strength training
virtual reality
plyometric exercises
cerebral palsy
hemiplegic
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Spasticity
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations