Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

FES Therapy:Restoring Voluntary Grasping Function in Chronic SCI

This study has been completed.
Sponsor:
Collaborator:
Rick Hansen Foundation
Information provided by (Responsible Party):
Milos Popovic, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT01208688
First received: September 23, 2010
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

The main objective of this study is to determine the effectiveness of a new treatment regime that uses electrical stimulation for the improvement of hand function in persons with spinal cord injuries (SCI). This treatment has been shown to be useful for stroke patients, and our preliminary work indicates that this may also be the case with SCI patients. Our approach to functional electrical stimulation (FES) represents a departure from the established FES approaches, which involve developing assistive devices for permanent, everyday use. Instead, we use FES as a therapeutic intervention that will help individuals with quadriplegia recover voluntary grasping function. Investigators believe that subjects who undergo FES therapy should be able to grasp objects without stimulation once the treatment program is completed.


Condition Intervention Phase
Spinal Cord Injuries
Device: FES Therapy
Other: Conventional Occupational Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FES Therapy:Restoring Voluntary Grasping Function in Chronic SCI

Resource links provided by NLM:


Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • REL Hand Function Test [ Time Frame: 45 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GRASSPGraded Redefined Assessment of Strength Sensibility and Prehension [ Time Frame: 60 min ] [ Designated as safety issue: No ]
  • Functional Independence Measures (FIM) [ Time Frame: 35 min ] [ Designated as safety issue: No ]
  • Spinal Cord Independence Measure (SCIM) [ Time Frame: 35 min ] [ Designated as safety issue: No ]
  • Client perception of treatment [ Time Frame: 15 min ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FES Therapy
FES Therapy
Device: FES Therapy
Treatment group received functional electrical stimulation and control group received conventional occupational therapy.
Other Name: Neuroprosthesis
Device: FES Therapy
Subjects will be divided into one of two groups: a) subjects that will be trained with neuroprosthesis for grasping and b) the control group. The control group will be administered standard occupational therapies appropriate for recovery of grasping function in SCI subjects. In group a), neuroprosthesis for grasping will be used to train subjects to reach, grasp and manipulate various objects in the activities of daily living.
Active Comparator: Conventional Occupational Therapy
The conventional therapy represents control activities against which FES therapy will be assessed. Conventional occupational therapy includes : a) muscle facilitation exercises emphasizing the neurodevelopmental treatment approach;b)task-specific repetitive functional training;c)strengthening and motor control training using resistance to available arm motion to increase strength; d)stretching exercises;e)electrical stimulation applied primarily for muscle strengthening (this is not FES); and f)activities of daily living including self care where the upper limb was used as an assist if appropriate; and caregiver training. Control and treatment group will have 3 sessions per week (business days only) for 13 to 16 weeks (40 treatment sessions in total). Each session will last 60 minutes.
Other: Conventional Occupational Therapy
The conventional therapy represents control activities against which FES therapy will be assessed. Conventional occupational therapy includes : a) muscle facilitation exercises emphasizing the neurodevelopmental treatment approach;b)task-specific repetitive functional training;c)strengthening and motor control training using resistance to available arm motion to increase strength; d)stretching exercises;e)electrical stimulation applied primarily for muscle strengthening (this is not FES); and f)activities of daily living including self care where the upper limb was used as an assist if appropriate; and caregiver training. Control and treatment group will have 3 sessions per week (business days only) for 13 to 16 weeks (40 treatment sessions in total). Each session will last 60 minutes.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • traumatic spinal cord lesion between C4 and C7
  • injury at least 24 months prior to enrolling in the study.

Exclusion criteria:

  • uncontrolled hypertension
  • susceptibility to autonomic dysreflexia
  • pressure ulcer
  • cardiac pacemaker
  • skin rash
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208688

Locations
Canada, Ontario
Toronto Rehabilitation Institute
Toronto, Ontario, Canada
Sponsors and Collaborators
Toronto Rehabilitation Institute
Rick Hansen Foundation
Investigators
Principal Investigator: Milos R Popovic, Ph.d Toronto Rehabilitation Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Milos Popovic, PhD, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT01208688     History of Changes
Other Study ID Numbers: 2009-36, SCISN-2009-36
Study First Received: September 23, 2010
Last Updated: September 24, 2012
Health Authority: Canada: Health Canada

Keywords provided by Toronto Rehabilitation Institute:
Spinal Cord Injuries

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014