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

NCT03600012 | Completed

• 1 other identifier: GO 14/119
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• Gait was assessed using a three-dimensional Gait Analysis motion system.

  Gait was assessed using a three-dimensional, seven-camera, VICON 512 motion measurement system (Oxford Metrics Ltd., Oxford, UK). The VICON Clinical Manager software was used for calculating and plotting temperospatial parameters, sagittal plane joint motion data, and kinematic data. Fifteen reflective markers were placed on specific anatomic landmarks bilaterally of the subject's pelvis, thighs, shanks and feet according to the marker protocol of Davis et al.

  change from baseline gross motor funciton at 8 weeks

• Walking energy expenditure measurements were done with breath by breath method.

  Walking energy expenditure measurements were done with breath by breath method using an open-circuit indirect calorimeter (Vmax 29c, Sensormedics, USA).

  change from baseline gross motor funciton at 8 weeks

Secondary Outcomes (7)

• Gross motor function was measured using GMFM.

  change from baseline gross motor funciton at 8 weeks

• Modified Ashworth (MAS) scale was used to evaluate muscle tone.

  change from baseline gross motor funciton at 8 weeks

• The 30s Repetition Maximum test was used to assess functional muscle strength of the lower extremities.

  change from baseline gross motor funciton at 8 weeks

• Balance was assessed with pediatric balance scale (PBS).

  change from baseline gross motor funciton at 8 weeks

• Dynamic balance was assessed withTime up & go test (TUG).

  change from baseline gross motor funciton at 8 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

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.

Other: Cycling Functional Electrical Stimulation; Other: Physiotherapy

control group

ACTIVE COMPARATOR

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.

Other: Physiotherapy

Interventions

Cycling Functional Electrical Stimulation OTHER

intervention group

Physiotherapy OTHER

control group; intervention group

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Related Publications (8)

• Kerr C, McDowell B, McDonough S. Electrical stimulation in cerebral palsy: a review of effects on strength and motor function. Dev Med Child Neurol. 2004 Mar;46(3):205-13. doi: 10.1017/s0012162204000349. No abstract available.

  PMID: 14995090 BACKGROUND

• 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.

  PMID: 24819681 BACKGROUND

• 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.

  PMID: 12161840 BACKGROUND

• 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.

  PMID: 20093327 BACKGROUND

• 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.

  PMID: 17374171 BACKGROUND

• 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.

  PMID: 17593125 BACKGROUND

• 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.

  PMID: 21527385 BACKGROUND

• 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.

  PMID: 21508913 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• yavuz yakut, prof.dr

  Hacettepe University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 3, 2018
• First Posted: July 26, 2018
• Study Start: September 1, 2014
• Primary Completion: April 15, 2015
• Study Completion: December 1, 2015
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share