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NCT Number: NCT03901703

The Effects of Functional Strengthening in Spastic Cerebral Palsy

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.

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Key information

Conditions

Spastic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, 06500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy and rehabilitation

Other

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Melek Volkan Yazici

Other

Registry information

Official study title

The Effects of Progressive Functional Ankle Strengthening in Children With Unilateral and Bilateral Spastic Cerebral Palsy

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 3, 2019
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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