The Effects of Functional Strengthening in Spastic Cerebral Palsy

Spastic Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901703
• Other study ID #: 465426
• Status: Completed
• Phase: N/A
• Start date: January 12, 2019
• Est. completion date: May 30, 2019

Study information

• Verified date: July 2019
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 30, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Spastic Cerebral Palsy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Melek Volkan Yazici

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.