Effects of Lower Extremities Cycling Functional Electrıcal Stimulation Training in Cerebral Palsy

NCT ID: NCT03600012

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-01
• Study Completion Date: 2015-12-01

Brief Summary

The aim of this study was to investigate the effects of cycling functional electrical stimulation applied to the lower extremities of children with spastic diplegic cerebral palsy (CP) on the gait parameters and daily living activities.

Detailed Description

Cerebral palsy (CP) is a broadly-defined neurological disorder that encompasses brain injury or malformation in a child's brain that occurs before, during, or immediately after birth and results in impaired motor control. Because of the broad definition of CP, people with CP can exhibit a very wide range of symptoms, and no two people with CP will exhibit the same symptoms. However, people with CP generally have difficulty moving parts of their bodies normally because of muscle weakness or paralysis, impaired muscle coordination, and/or spasticity. Impaired motor control can also be accompanied by intellectual impairment, seizures, or sensory impairment.

Physical impairment can severely limit participation in physical activity by people with CP, as is true for anyone with physical impairments. Lack of physical activity can lead to the development of any number of chronic diseases, especially in children with disabilities like CP. Exercise is an effective method for mitigating the negative secondary health effects of neuromuscular diseases like CP, but how can someone with CP exercise despite their impaired motor control, especially when 31% of children with CP have limited walking ability.

Cycling is an exercise that challenges the muscular and cardiovascular systems, potentially leading to improved health, fitness, and well-being. Cycling with functional electrical stimulation (FES) has been primarily used by people with spinal cord injury; improvements have been seen in bone mineral density, muscle strength (force-generating capacity), and cardiorespiratory measures. Recent reports indicated benefits for people after stroke; improvements in strength and motor control were seen when an FES cycling program was added to traditional rehabilitation. However, there have been no reports of FES cycling for children with CP.

Cycling with FES may be a suitable intervention for with CP because the seated position decreases balance demands, and FES can create or augment pedaling forces. Many people with CP may be incapable of generating sufficient forces during cycling to reach the exercise intensity needed for optimal fitness-related outcomes and musculoskeletal benefits.

Conditions

Cerebral Palsy; Diplegic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervention group

intervention group: Cycling Functional Electrical Stimulation & Physiotherapy

Children in intervention group were taken in a therapy program withRT 300 SLSA FES system for cycling functional electrical stimulation training additionly to physiotherapy program including weight shifting, knee and hip strenging and gait training for 8 weeks, 3 sessions in a week and 45 min per session.

Group Type: EXPERIMENTAL

Cycling Functional Electrical Stimulation

Intervention Type: OTHER

Physiotherapy

Intervention Type: OTHER

control group

control group: Physiotherapy

Children with cp in control group were taken physiotherapy program including weight shifting, knee and hip strenging and gait training for 8 weeks, 3 times in a week, 45 min per session.

Group Type: ACTIVE_COMPARATOR

Physiotherapy

Intervention Type: OTHER

Interventions

Cycling Functional Electrical Stimulation

Intervention Type: OTHER

Physiotherapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• cerebral palsy
• classified in levels I - II of the Gross Motor Function Classification System (GMFCS)
• able to follow and accept verbal instruction

Exclusion Criteria

• any orthopaedic surgery or botulinum toxin injection in the past 6 months,
• children whose parents refused to participate

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Duygu Turker

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yavuz yakut, prof.dr

Role: STUDY_CHAIR

Hacettepe University

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 21527385 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 21508913 (View on PubMed)

Other Identifiers

GO 14/119

Identifier Type: -

Identifier Source: org_study_id