FES Therapy:Restoring Voluntary Grasping Function in Chronic SCI

NCT01208688 | Completed Phase 2

• 2 other identifiers: 2009-36SCISN-2009-36
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• REL Hand Function Test

  45 min

Secondary Outcomes (4)

• GRASSPGraded Redefined Assessment of Strength Sensibility and Prehension

  60 min

• Functional Independence Measures (FIM)

  35 min

• Spinal Cord Independence Measure (SCIM)

  35 min

• Client perception of treatment

  15 min

Study Arms (2)

FES Therapy

EXPERIMENTAL

FES Therapy

Device: FES Therapy

Conventional Occupational Therapy

ACTIVE COMPARATOR

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

Interventions

FES Therapy DEVICE

Treatment group received functional electrical stimulation and control group received conventional occupational therapy.

Also known as: Neuroprosthesis

FES Therapy

Conventional Occupational Therapy OTHER

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.

Conventional Occupational Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• uncontrolled hypertension
• susceptibility to autonomic dysreflexia
• pressure ulcer
• cardiac pacemaker
• skin rash

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead
• Rick Hansen Foundation: collaborator

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Location

Related Links

• Rehabilitation Engineering Laboratory

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Milos R Popovic, Ph.d

  Toronto Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 24, 2010
• Study Start: September 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

CA (1)