The Effects of Functional Strengthening in Spastic Cerebral Palsy

NCT03901703 | Completed DMC

• 1 other identifier: 465426
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Spastic Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (3)

Dorsiflexor Muscle Strengthening Group

ACTIVE COMPARATOR

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

Plantarflexor Muscle Strengthening Group

ACTIVE COMPARATOR

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

Dorsiflexor and Plantarflexor Muscle strengthening Group

ACTIVE COMPARATOR

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

Interventions

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.

Dorsiflexor Muscle Strengthening Group; Dorsiflexor and Plantarflexor Muscle strengthening Group; Plantarflexor Muscle Strengthening Group

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Melek Volkan Yazici: lead

Study Sites (1)

Gazi University

Ankara, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities; Rehabilitation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Bulent Elbasan, Assoc. Prof.

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: January 12, 2019
• Primary Completion: May 15, 2019
• Study Completion: May 30, 2019
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)