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Benefits of Applying Neuroprosthesis to Improve Grasping and Reaching in Spinal Cord Injury Patients

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ClinicalTrials.gov Identifier: NCT00221117
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : November 20, 2017
Last Update Posted : July 24, 2018
Sponsor:
Collaborators:
Christopher Reeve Paralysis Foundation
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Milos Popovic, Toronto Rehabilitation Institute

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 22, 2005
Results First Submitted Date  ICMJE May 8, 2012
Results First Posted Date  ICMJE November 20, 2017
Last Update Posted Date July 24, 2018
Study Start Date  ICMJE August 2005
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2017)
Functional Independence Measure (FIM) [ Time Frame: 35 min ]
Functional Independent Measure was employed to measure the degree of disability for daily self care. It capture data on self-care, sphincter management, transfers,locomotion,communication,and social cognition.The scale is divided according to no helper category (level 6 and 7) where no other person is required to help with the activity and a hel;per category(level 1 through 5)where the patient needs minimal to total assistance from another person to accomplish the activity Score range from 18-126. Higher values represent a better outcome.
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
  • Functional Independence Measure (FIM)
  • Rehabilitation Engineering Laboratory (REL) Hand Function Test
  • Bend Sensor Glove for Grasp
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
  • Rehabilitation Engineering Laboratory Hand Function Test(REL Test) [ Time Frame: 45 min ]
    The Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) evaluates gross motor function of unilateral grasp (also referred to as the Rehabilitation Engineering Laboratory Hand Function Test). Hand functions that are assessed with TRI-HFT include the following: lateral or pulp pinch and palmar grasp.Score range from 0-70. Higher values represent a better outcome.
  • Spinal Cord Independence Measure (SCIM). [ Time Frame: 30 min ]
    Score range from 0-100. Higher score represent a better outcome.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
  • The Klein-Bell ADL (Activities of Daily Living) Scale
  • -Client perception of treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Benefits of Applying Neuroprosthesis to Improve Grasping and Reaching in Spinal Cord Injury Patients
Official Title  ICMJE Neuroprosthesis for Improving Grasping Function in Spinal Cord Injured Patients
Brief Summary Functional electrical stimulation is a process that uses low intensity electrical pulses generated by an electric stimulator to create muscle contractions. By contracting muscles in a specific sequence, one can generate various body functions such as grasping, walking, and standing.The study is designed to evaluate the effectiveness and long term benefits of applying functional electrical simulation during early rehabilitation to improve grasping function in persons who have suffered a spinal cord injury. By using functional electrical stimulation,these patients could potentially improve their grasping function.
Detailed Description

The main objective of this study is to determine the effectiveness of a new treatment regime that uses a neuroprosthesis for the improvement and recovery of grasping functions in persons with spinal cord injuries (SCI). This treatment has been shown to be useful for stroke patients with hemiplegic arm in the recovery of reaching and grasping 1, and our preliminary work indicates that this may also be the case with SCI patients 3. Further, aside from the potential of promoting voluntary grasp in SCI patients, this novel therapeutic approach may also impact the way service is currently delivered in SCI rehabilitation settings.

A neuroprosthesis for grasping is a device that can improve or restore the grasping, holding, and releasing functions in persons with SCI 2, 3. The neuroprosthesis applies functional electrical stimulation (FES) to artificially generate a muscle contraction by applying short current pulses to motor nerves innervating muscles. FES can be applied to individuals with incomplete SCI to help them restore functions such as walking and grasping by contracting groups of paralyzed muscles in an orchestrated manner 4. FES was originally envisioned as an intervention that was 'permanent' in nature. In other words, an individual had to wear/use an FES orthotic device at all times if s/he wanted to generate the function that was impaired by SCI 4. Our application of the neuroprosthesis for grasping in this proposal presents a departure from this standard and established approach of FES application. Rather than having people be dependent on the neuroprosthesis to perform their activities of daily living (ADL), we plan to use the neuroprosthesis for grasping as a short-term intervention that will help SCI individuals recover voluntary grasping function. Hence, we believe that those participants who undergo our FES therapy with the neuroprosthesis should be able to perform grasping functions without its use once the treatment program is completed.

Recent innovative advances in FES applications, spearheaded by our team, clearly indicate that the short-term, therapeutic intervention of the neuroprosthesis for grasping can enhance voluntary function in individuals with SCI 3, 5, 6. These studies also suggest that this novel method of applying FES to augment functional improvement has the potential to improve overall physical and psychological well being of persons with incomplete SCI. Since 1999, the Co-PI of this application, Dr. Milos Popovic and Dejan Popovic's team from the University of Belgrade have reported anecdotal evidence that some C5 to C7 SCI individuals who were unable to voluntarily grasp, were later able to do so after intensive training with a neuroprosthesis for grasping 2, 7, 8, 9. They observed that approximately 20 to 25% of the individuals who trained with the FES systems were able to grasp without the assistance of the neuroprosthesis once the systems were removed. Although this evidence has been presented in several peer-reviewed publications, there have been no comprehensive studies to date that have investigated the long-term effects of FES treatment on recovery of the voluntary grasping function in persons with SCI. Consequently, this study seeks to 1) investigate whether a series of orchestrated FES therapies can be applied to re-train/improve voluntary grasping function in acute SCI individuals, and; 2) to determine whether this therapy will yield better results than conventional occupational therapy. Specifically, we will recruit participants who have C5 to C7 incomplete SCI. These individuals typically can generate weak wrist extension but can neither flex, extend, abduct or adduct the fingers, nor flex, extend, abduct or adduct the thumb. Our therapy will be used to help these individuals recover some or all of these functions.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE
  • Device: Neuroprosthesis-FES Therapy
    The Compex Motion neuroprostesis, developed by Drs. R. Popovic and Thierry Keller,and company Compex SA, ia a flexible device designed to improve grasping function in both SCI and stroke patients.This multi-channel surface stimulation system for grasping provides both palmar and lateral grasp , and holds a number of advantages over the other existing neuroprostheses.
    Other Name: Neuroprosthesis
  • Other: Conventional Ocupational Therapy (COT)
    Conventional occupational therapy pertaining to hand function represents control activities against which the FES therapy was assessed. The conventional occupational therapy included: 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 but TENS application); f) activities of daily living including self-care where the upper limb was used as an assist if appropriate; and g) caregiver training.
    Other Name: Conventional Occupational Therapy (COT)
Study Arms  ICMJE
  • Active Comparator: Conventional Occupational Therapy (COT)
    Conventional Occupational Therapy pertaining to hand function represents the current best practice activities against which the FET was compared. The COT included the following: (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 was neither FES nor FET, but electro muscular stimulation); (f) practice of activities of daily living (ADLs) including self-care where the upper extremities were used as appropriate; and (g) caregiver training.
    Intervention: Other: Conventional Ocupational Therapy (COT)
  • Experimental: Neuroprosthesis-FES Therapy
    The FES Therapy began by designing stimulation protocols to generate power (circular grip and lateral pinch) and precision (opposition with 2 and 3 fingers) grasps on demand. The stimulation sequence (protocol) for power and precision grasps was developed for each patient individually using the Compex Motion electric stimulator. Compex Motion is a fully programmable transcutaneous (surface) stimulator that uses self-adhesive surface electrodes.
    Intervention: Device: Neuroprosthesis-FES Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2017)
22
Original Enrollment  ICMJE
 (submitted: September 14, 2005)
40
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • traumatic spinal cord lesion between C4 and C7(incomplete)
  • participants will be recruited during the first six months post-SCI.

Exclusion Criteria:

  • uncontrolled hypertension
  • susceptibility to autonomic dysreflexia
  • pressure ulcer
  • cardiac pacemakers
  • skin rush
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00221117
Other Study ID Numbers  ICMJE TRI REB #02-032
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD will not be shared , mean results of the study have been published in the peer reviewed paper.
Responsible Party Milos Popovic, Toronto Rehabilitation Institute
Study Sponsor  ICMJE Toronto Rehabilitation Institute
Collaborators  ICMJE
  • Christopher Reeve Paralysis Foundation
  • The Physicians' Services Incorporated Foundation
Investigators  ICMJE
Principal Investigator: Milos Popovic, Ph.D University of Toronto
PRS Account Toronto Rehabilitation Institute
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP