search
Back to results

The Effects of Functional Strengthening in Spastic Cerebral Palsy

Primary Purpose

Spastic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physiotherapy and Rehabilitation
Sponsored by
Melek Volkan Yazici
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Cerebral Palsy

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gazi University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Dorsiflexor Muscle Strengthening Group

Plantarflexor Muscle Strengthening Group

Dorsiflexor and Plantarflexor Muscle strengthening Group

Arm Description

The children in this group will receive functional exercises aiming to strengthen their dorsiflexor muscles alongside standard functional progressive strengthening exercises.

The children in this group will receive functional exercises aiming to strengthen their plantarflexor muscles alongside standard functional progressive strengthening exercises.

The children in this group will receive functional exercises aiming to strengthen both their dorsiflexor and plantarflexor muscles alongside standard functional progressive strengthening exercises.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 1, 2019
Last Updated
July 29, 2019
Sponsor
Melek Volkan Yazici
search

1. Study Identification

Unique Protocol Identification Number
NCT03901703
Brief Title
The Effects of Functional Strengthening in Spastic Cerebral Palsy
Official Title
The Effects of Progressive Functional Ankle Strengthening in Children With Unilateral and Bilateral Spastic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 12, 2019 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Melek Volkan Yazici

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dorsiflexor Muscle Strengthening Group
Arm Type
Active Comparator
Arm Description
The children in this group will receive functional exercises aiming to strengthen their dorsiflexor muscles alongside standard functional progressive strengthening exercises.
Arm Title
Plantarflexor Muscle Strengthening Group
Arm Type
Active Comparator
Arm Description
The children in this group will receive functional exercises aiming to strengthen their plantarflexor muscles alongside standard functional progressive strengthening exercises.
Arm Title
Dorsiflexor and Plantarflexor Muscle strengthening Group
Arm Type
Active Comparator
Arm Description
The children in this group will receive functional exercises aiming to strengthen both their dorsiflexor and plantarflexor muscles alongside standard functional progressive strengthening exercises.
Intervention Type
Other
Intervention Name(s)
Physiotherapy and Rehabilitation
Intervention Description
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 Measure Information:
Title
Pediatric Balance scale
Description
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.
Time Frame
Change of The Pediatric balance scale at 6 weeks.
Title
Surface Electromyography (sEMG)
Description
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.
Time Frame
Change of sEMG data at 6 weeks.
Title
The Six minute walk test
Description
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.
Time Frame
Change of 6 MWT at 6 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bulent Elbasan, Assoc. Prof.
Organizational Affiliation
Gazi University
Official's Role
Study Director
Facility Information:
Facility Name
Gazi University
City
Ankara
ZIP/Postal Code
06500
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The exercise protocols and results will be shared with other investigators.

Learn more about this trial

The Effects of Functional Strengthening in Spastic Cerebral Palsy

We'll reach out to this number within 24 hrs