Clinical trial NCT03600012: Effects of Lower Extremities Cycling Functional Electrıcal Stimulation Training in Cerebral Palsy
Official title: Investigating of Effects of Lower Extremities Cycling Functional Electrıcal Stimulation Training On Gait Parameters In Children With Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Diplegic Cerebral Palsy
Keywords: Diplegic Cerebral Palsy
Cycling With Functional Electrical Stimulation
Gait Analysis
Functional Strenght Training
Quality of Life
Qxygen Consumption
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Gait was assessed using a three-dimensional Gait Analysis motion system.
timeFrame: change from baseline gross motor funciton at 8 weeks
measure: Walking energy expenditure measurements were done with breath by breath method.
timeFrame: change from baseline gross motor funciton at 8 weeks
Secondary outcomes:
measure: Gross motor function was measured using GMFM.
timeFrame: change from baseline gross motor funciton at 8 weeks
measure: Modified Ashworth (MAS) scale was used to evaluate muscle tone.
timeFrame: change from baseline gross motor funciton at 8 weeks
measure: The 30s Repetition Maximum test was used to assess functional muscle strength of the lower extremities.
timeFrame: change from baseline gross motor funciton at 8 weeks
measure: Balance was assessed with pediatric balance scale (PBS).
timeFrame: change from baseline gross motor funciton at 8 weeks
measure: Dynamic balance was assessed withTime up & go test (TUG).
timeFrame: change from baseline gross motor funciton at 8 weeks
measure: Daily living activity was assessed with Pediatric Evaluation of Disability Inventory.
timeFrame: change from baseline gross motor funciton at 8 weeks
measure: Quality of life was assessed withThe Child Health Questionnaire (CHQ-PF50).
timeFrame: change from baseline gross motor funciton at 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University
name: yavuz yakut, prof.dr
role: STUDY_CHAIR
References:
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citation: Chiu HC, Ada L. Effect of functional electrical stimulation on activity in children with cerebral palsy: a systematic review. Pediatr Phys Ther. 2014 Fall;26(3):283-8. doi: 10.1097/PEP.0000000000000045.
citation: Dodd KJ, Taylor NF, Damiano DL. A systematic review of the effectiveness of strength-training programs for people with cerebral palsy. Arch Phys Med Rehabil. 2002 Aug;83(8):1157-64. doi: 10.1053/apmr.2002.34286.
citation: Fowler EG, Knutson LM, Demuth SK, Siebert KL, Simms VD, Sugi MH, Souza RB, Karim R, Azen SP; Physical Therapy Clinical Research Network (PTClinResNet). Pediatric endurance and limb strengthening (PEDALS) for children with cerebral palsy using stationary cycling: a randomized controlled trial. Phys Ther. 2010 Mar;90(3):367-81. doi: 10.2522/ptj.20080364. Epub 2010 Jan 21.
citation: Fowler EG, Knutson LM, DeMuth SK, Sugi M, Siebert K, Simms V, Azen SP, Winstein CJ. Pediatric endurance and limb strengthening for children with cerebral palsy (PEDALS)--a randomized controlled trial protocol for a stationary cycling intervention. BMC Pediatr. 2007 Mar 21;7:14. doi: 10.1186/1471-2431-7-14.
citation: Williams H, Pountney T. Effects of a static bicycling programme on the functional ability of young people with cerebral palsy who are non-ambulant. Dev Med Child Neurol. 2007 Jul;49(7):522-7. doi: 10.1111/j.1469-8749.2007.00522.x.
citation: Johnston TE, Wainwright SF. Cycling with functional electrical stimulation in an adult with spastic diplegic cerebral palsy. Phys Ther. 2011 Jun;91(6):970-82. doi: 10.2522/ptj.20100286. Epub 2011 Apr 28.
citation: Trevisi E, Gualdi S, De Conti C, Salghetti A, Martinuzzi A, Pedrocchi A, Ferrante S. Cycling induced by functional electrical stimulation in children affected by cerebral palsy: case report. Eur J Phys Rehabil Med. 2012 Mar;48(1):135-45. Epub 2011 Apr 20.