FES Therapy:Restoring Voluntary Grasping Function in Chronic SCI - Full Text View

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:

MedlinePlus related topics: Rehabilitation Spinal Cord Injuries

U.S. FDA Resources

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.

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

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:

Rehabilitation Engineering Laboratory This link exits the ClinicalTrials.gov site

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
Spinal Cord Diseases
Central Nervous System Diseases

Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013