The Effects of Functional Strengthening in Spastic Cerebral Palsy

The Effects of Progressive Functional Ankle Strengthening in Children With Unilateral and Bilateral 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.

Study Overview

• Status: Completed
• Conditions: Spastic Cerebral Palsy
• Intervention / Treatment: Other: Physiotherapy and Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06500
    • Gazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Balance scale	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.	Change of The Pediatric balance scale at 6 weeks.
Surface Electromyography (sEMG)	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.	Change of sEMG data at 6 weeks.
The Six minute walk test	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.	Change of 6 MWT at 6 weeks.

Collaborators and Investigators

• Sponsor: Melek Volkan Yazici
• Investigators: Study Director: Bulent Elbasan, Assoc. Prof., Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2019
• Primary Completion (Actual): May 15, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: 465426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The exercise protocols and results will be shared with other investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No