Functional Electrical Stimulation (FES) for Upper Extremity Hemiplegia in Children With Cerebral Palsy

NCT03016923 | Completed

• 1 other identifier: 15-549
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

The proposed pilot study seeks to explore the effectiveness of Functional Electrical Stimulation (FES) to improve upper limb function in children and youth (aged 6 to 18 years) with hemiplegic cerebral palsy, as measured by the QUEST grasp score and other secondary outcome measures obtained pre- and post-intervention in a case series study design.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; hemiplegia; fes; grasping

Outcome Measures

Primary Outcomes (1)

• Quality of Upper Extremities Skills Test (QUEST) as a measure of Movement patterns and hand function

  Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention

Secondary Outcomes (7)

• Canadian Occupational Performance Measure (COPM) as a measure of change in a child's self-perception of occupational performance over time

  Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention

• Grip Strength Test as a measure of hand and forearm muscular strength

  Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention

• Jebsen-Taylor Test of Hand Function (JTTHF) as a measure of hand functions required in activities of daily living

  Change from Baseline (i.e., prior to intervention), at 4 months post-intervention, and at 6 months post-intervention. JTTHF will also be assessed at 4 weeks, 8 weeks, 12 weeks, and 16 weeks during the intervention period.

• Children's Hand-use Experience Questionnaire (CHEQ) as a measure of children's experience in using the affected hand in bi-manual activities

  Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention

• Proprioception Task as a measure of joint-position sense

  Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention

Study Arms (1)

FES Therapy

EXPERIMENTAL

FES therapy will be administered over the course of 1 hour sessions that will be take place 3 times per week over 16 weeks, for a total of 48 sessions.

Device: FES Therapy

Interventions

FES Therapy DEVICE

FES therapy will be administered over the course of 1 hour sessions that will be take place 3 times per week over 16 weeks, for a total of 48 sessions.

FES Therapy

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of hemiplegic CP
• Age between 6 to 18 years
• Ability to cooperate, understand and follow instructions during the administration of FES paired with intensive hand therapy
• Baseline total QUEST score between 20-80 out of 100 points
• Be seizure-free for a required period of at least 1 year with or without medication , and have no prior history of known cardiac arrhythmias/stimulants
• No pacemaker or implanted metallic or electronic device
• No edema, skin rash, allergy or wound on the affected upper limb where FES will be administered.
• No Botulinum toxin upper limb injections within 6-months of study entry, and no Constraint-induced movement therapy (CIMT) within 4 months of study entry. Participants should also refrain from receiving these treatments throughout the duration of the study.

You may not qualify if:

• The participant's forearm is too small to accommodate the standard FES electrodes.
• The participant's muscles do not respond to the electrical stimulation as tested at the baseline assessment visit. Response to electrical stimulation will be tested at the baseline visit and is described in detail in the section entitled "Muscle Responsiveness Testing" below. Based on the Muscle Responsiveness Testing procedures and criteria, the withdrawal criteria for non-response to electrical stimulation is defined as:
• More than 3 muscle groups out of 11 not- responding to FES or
• The participant reports a discomfort level score of 8 or 10 on the FACES scale (Appendix A) for any of the 11 muscle groups.
• Participant receives any other active occupational therapy or hemiplegic hand intervention during the FES intervention period.
• Participant attends less than 36/48 FES intervention sessions.
• Participant develops new-onset seizures during the FES intervention period.

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead

Related Publications (11)

• Kapadia NM, Nagai MK, Zivanovic V, Bernstein J, Woodhouse J, Rumney P, Popovic MR. Functional electrical stimulation therapy for recovery of reaching and grasping in severe chronic pediatric stroke patients. J Child Neurol. 2014 Apr;29(4):493-9. doi: 10.1177/0883073813484088. Epub 2013 Apr 12.

  PMID: 23584687 BACKGROUND

• Thrasher TA, Zivanovic V, McIlroy W, Popovic MR. Rehabilitation of reaching and grasping function in severe hemiplegic patients using functional electrical stimulation therapy. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):706-14. doi: 10.1177/1545968308317436.

  PMID: 18971385 BACKGROUND

• Kawashima N, Popovic MR, Zivanovic V. Effect of intensive functional electrical stimulation therapy on upper-limb motor recovery after stroke: case study of a patient with chronic stroke. Physiother Can. 2013 Winter;65(1):20-8. doi: 10.3138/ptc.2011-36.

  PMID: 24381377 BACKGROUND

• Sheffler LR, Chae J. Neuromuscular electrical stimulation in neurorehabilitation. Muscle Nerve. 2007 May;35(5):562-90. doi: 10.1002/mus.20758.

  PMID: 17299744 BACKGROUND

• Quandt F, Hummel FC. The influence of functional electrical stimulation on hand motor recovery in stroke patients: a review. Exp Transl Stroke Med. 2014 Aug 21;6:9. doi: 10.1186/2040-7378-6-9. eCollection 2014.

  PMID: 25276333 BACKGROUND

• Meadmore KL, Exell TA, Hallewell E, Hughes AM, Freeman CT, Kutlu M, Benson V, Rogers E, Burridge JH. The application of precisely controlled functional electrical stimulation to the shoulder, elbow and wrist for upper limb stroke rehabilitation: a feasibility study. J Neuroeng Rehabil. 2014 Jun 30;11:105. doi: 10.1186/1743-0003-11-105.

  PMID: 24981060 BACKGROUND

• Golomb MR, Garg BP, Saha C, Azzouz F, Williams LS. Cerebral palsy after perinatal arterial ischemic stroke. J Child Neurol. 2008 Mar;23(3):279-86. doi: 10.1177/0883073807309246.

  PMID: 18305317 BACKGROUND

• Prosser LA, Curatalo LA, Alter KE, Damiano DL. Acceptability and potential effectiveness of a foot drop stimulator in children and adolescents with cerebral palsy. Dev Med Child Neurol. 2012 Nov;54(11):1044-9. doi: 10.1111/j.1469-8749.2012.04401.x. Epub 2012 Aug 27.

  PMID: 22924431 BACKGROUND

• Wright PA, Granat MH. Therapeutic effects of functional electrical stimulation of the upper limb of eight children with cerebral palsy. Dev Med Child Neurol. 2000 Nov;42(11):724-7. doi: 10.1017/s0012162200001341.

  PMID: 11104342 BACKGROUND

• Postans NJ, Granat MH. Effect of functional electrical stimulation, applied during walking, on gait in spastic cerebral palsy. Dev Med Child Neurol. 2005 Jan;47(1):46-52. doi: 10.1017/s0012162205000083.

  PMID: 15686289 BACKGROUND

• Staudt M, Gerloff C, Grodd W, Holthausen H, Niemann G, Krageloh-Mann I. Reorganization in congenital hemiparesis acquired at different gestational ages. Ann Neurol. 2004 Dec;56(6):854-63. doi: 10.1002/ana.20297.

  PMID: 15562409 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Darcy Fehlings, MD, MSc

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: January 11, 2017
• Study Start: March 1, 2016
• Primary Completion: August 25, 2017
• Study Completion: August 25, 2017
• Last Updated: February 26, 2018

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share