Progressive Functional Strength Training in Unilateral Spastic Cerebral Palsy
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ClinicalTrials.gov Identifier: NCT02460406 |
Recruitment Status :
Completed
First Posted : June 2, 2015
Last Update Posted : May 23, 2016
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Condition or disease | Intervention/treatment | Phase |
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Spastic Hemiplegic Cerebral Palsy | Other: traditional physiotherapy Other: progressive functional strength training | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
control group
traditional physiotherapy (stretching, normal range of movement, walking)
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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.
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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. |
- 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.
- 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.
- muscle tone [ Time Frame: change from basaline muscle tone at 12 weeks ]modified Tardieu scale was used to evaluate muscle tone.
- balance [ Time Frame: change from basaline balance at 12 week ]Dynamic balance was assessed with Time up & go and functional reaching test.
- 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.
- muscle performance [ Time Frame: change from basaline muscle performance at 12 weeks ]Standing Broad Jump and vertical jump was used to evaluate muscle performance.
- 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.
- Agility [ Time Frame: change from basaline agility at 12 weeks ]Agility was measured via using the 10x5m sprint test.

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Ages Eligible for Study: | 7 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Turkey | |
Hacettepe University | |
Ankara, Turkey, 06100 |
Study Director: | Ozgun Kaya Kara, PhD | Hacettepe University |
Publications:
Responsible Party: | Ozgun Kaya Kara, PT, PhD, Hacettepe University |
ClinicalTrials.gov Identifier: | NCT02460406 |
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 |
strength training virtual reality plyometric exercises cerebral palsy hemiplegic |
Muscle Spasticity Paralysis Cerebral Palsy Neurologic Manifestations Nervous System Diseases Brain Damage, Chronic |
Brain Diseases Central Nervous System Diseases Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations |