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The Effects of Functional Strengthening in Spastic Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03901703
Recruitment Status : Completed
First Posted : April 3, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Melek Volkan Yazici, Gazi University

Brief Summary:
Functional strengthening exercises have been proven to be effective in patients with spastic cerebral palsy. However, which exercise is the most effective is unknown. The aim of this study is to examine the effectiveness of three different progressive functional exercise programs in children with unilateral and bilateral spastic cerebral palsy.

Condition or disease Intervention/treatment Phase
Spastic Cerebral Palsy Other: Physiotherapy and Rehabilitation Not Applicable

Detailed Description:
Children with Cerebral Palsy have weakness in thier muscles due to cortical lesions leading to deficiencies in motor control, balance and functional abilities. All children with Cerebral Palsy have shown to present with foot and ankle disorders; the ankle dorsi and plantar flexor muscles are both problematic; the plantarflexors are usually spastic and the dorsiflexors are usually not active enough and usually these muscle problems lead to problems in the childrens' gait abilities. When rehabilitation programs are examined, the results of exercises addressing these problems do not have precise answers. Functional strengthening exercises have been proven to be effective in patients with spastic cerebral palsy. However, which exercise is the most effective is unknown. Which muscle goup has the most effect on gait, balance and functional activities is still unclear. Therefore, the investigator's aim in planning this study is to examine the effectiveness of three progressive functional exercise programs in children with unilateral and bilateral spastic cerebral palsy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Progressive Functional Ankle Strengthening in Children With Unilateral and Bilateral Spastic Cerebral Palsy
Actual Study Start Date : January 12, 2019
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dorsiflexor Muscle Strengthening Group
The children in this group will receive functional exercises aiming to strengthen their dorsiflexor muscles alongside standard functional progressive strengthening exercises.
Other: Physiotherapy and Rehabilitation
The children in each group will receive 6 weeks of functional strengthening exercises targeting each muscle group according to the arm they are included in.

Active Comparator: Plantarflexor Muscle Strengthening Group
The children in this group will receive functional exercises aiming to strengthen their plantarflexor muscles alongside standard functional progressive strengthening exercises.
Other: Physiotherapy and Rehabilitation
The children in each group will receive 6 weeks of functional strengthening exercises targeting each muscle group according to the arm they are included in.

Active Comparator: Dorsiflexor and Plantarflexor Muscle strengthening Group
The children in this group will receive functional exercises aiming to strengthen both their dorsiflexor and plantarflexor muscles alongside standard functional progressive strengthening exercises.
Other: Physiotherapy and Rehabilitation
The children in each group will receive 6 weeks of functional strengthening exercises targeting each muscle group according to the arm they are included in.




Primary Outcome Measures :
  1. Pediatric Balance scale [ Time Frame: Change of The Pediatric balance scale at 6 weeks. ]
    The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.

  2. Surface Electromyography (sEMG) [ Time Frame: Change of sEMG data at 6 weeks. ]
    Surface electromyography is a non-invasive procedure involving the detection, recording and interpretation of the electric activity of groups of muscles during activity. The procedure is performed using electrodes placed on the skin surface over the muscles to be tested. sEMG is also used to assess the effects of rehabilitation programs and evaluate muscular function in children with cerebral palsy. Due to its non-invasive properties it is safely and widely used in the pediatric population.

  3. The Six minute walk test [ Time Frame: Change of 6 MWT at 6 weeks. ]
    The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. The test has been shown to be valid and reliable in children with Cerebral Palsy.



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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Accepting to participate in the study,
  • Being between 5-15 years old,
  • Having a diagnosis of Spastic Cerebral Palsy,
  • Being level I-II according to GMFCS,

Exclusion Criteria:

  • Having limited cooperation which prevents participation in the study,
  • Refusing to participate in the study,
  • Having an orthopedic disorder or systemic illness which prevents movement in the lower extremities,
  • Having a Botulinum toxin application in the last 3 months

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): NCT03901703


Locations
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Turkey
Gazi University
Ankara, Turkey, 06500
Sponsors and Collaborators
Melek Volkan Yazici
Investigators
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Study Director: Bulent Elbasan, Assoc. Prof. Gazi University
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Responsible Party: Melek Volkan Yazici, Principle Investigator, Gazi University
ClinicalTrials.gov Identifier: NCT03901703    
Other Study ID Numbers: 465426
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The exercise protocols and results will be shared with other investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Spasticity
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations