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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Spinal Cord Injuries
Interventions Device: Neuroprosthesis-FES Therapy
Other: Conventional Ocupational Therapy (COT)
Enrollment 22
Recruitment Details Subjects were randomized using 2 sets of sealed envelopes. Each unmarked envelope contained a single sheet of paper with a printed number in the range of 1 to 40. A second set of envelopes was marked with numbers from 1 to 40 and contained a single sheet specifying the group allocation.
Pre-assignment Details If participant did not meet inclusion criteria they would be excluded
Arm/Group Title Conventional Occupational Therapy-Control Group Fes Therapy-Treatment Group
Hide Arm/Group Description 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. The FET 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.
Period Title: Overall Study
Started 12 9 [1]
Completed 12 9
Not Completed 0 0
[1]
One participant dropped out of the study after signing consent but prior to baseline assessments.
Arm/Group Title Conventional Occupational Therapy-Control Group Fes Therapy-Treatment Group Total
Hide Arm/Group Description 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. The FET 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. Total of all reporting groups
Overall Number of Baseline Participants 12 9 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 9 participants 21 participants
<=18 years
0
   0.0%
1
  11.1%
1
   4.8%
Between 18 and 65 years
11
  91.7%
7
  77.8%
18
  85.7%
>=65 years
1
   8.3%
1
  11.1%
2
   9.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 9 participants 21 participants
44.75  (4.72) 43.2  (5.45) 43.975  (5.085)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 9 participants 21 participants
Female
3
  25.0%
2
  22.2%
5
  23.8%
Male
9
  75.0%
7
  77.8%
16
  76.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 12 participants 9 participants 21 participants
12 9 21
1.Primary Outcome
Title Functional Independence Measure (FIM)
Hide Description 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.
Time Frame 35 min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FES Therapy Conventional Occupational Therapy
Hide Arm/Group Description:
The Functional Independence Measure (FIM)15 was employed to measure the degree of disability for daily self-care.
The Functional Independence Measure (FIM)15 was employed to measure the degree of disability for daily self-care.
Overall Number of Participants Analyzed 9 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.1  (9.87) 10  (9.065)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FES Therapy, Conventional Occupational Therapy
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .015
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Rehabilitation Engineering Laboratory Hand Function Test(REL Test)
Hide Description 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.
Time Frame 45 min
Hide Outcome Measure Data
Hide Analysis Population Description
The subject's impairment and demographic characteristics were analyzed using descriptive statistics for parametric and nonparametric data.
Arm/Group Title FES Group Conventional Occupational Therapy
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 9 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.7  (14.80) 11.3  (9.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FES Group
Comments The subject's impairment and demographic characteristics were analyzed using descriptive statistics for parametric and nonparametric data. The baseline outcome data of the intervention and control groups were compared using Fisher exact test (for categorical variables) and Mann-Whitney U test (for continuous variables). Comparisons between the intervention and control groups were carried out using linear regression analysis adjusted for the baseline degree of disability (baseline AIS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
3.Secondary Outcome
Title Spinal Cord Independence Measure (SCIM).
Hide Description Score range from 0-100. Higher score represent a better outcome.
Time Frame 30 min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FES Therapy Conventional Occupational Therapy
Hide Arm/Group Description:
The Functional Independence Measure (FIM)15 was employed to measure the degree of disability for daily self-care.
The Functional Independence Measure (FIM)15 was employed to measure the degree of disability for daily self-care.
Overall Number of Participants Analyzed 9 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.1  (3.8) 3.1  (2.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Fes Therapy-Treatment Group
Hide Arm/Group Description Conventional Occupational Therapy The FET 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.
All-Cause Mortality
Control Group Fes Therapy-Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Control Group Fes Therapy-Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group Fes Therapy-Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/9 (0.00%) 
A limitation of this study is that despite considerable effort we failed to attract the subjects to take part in a 6-month follow- up assessment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Milos Popovic
Organization: Toronto RI Institute
Phone: 416-597-3422 ext 6305
EMail: milos.popovic@utoronto.ca
Layout table for additonal information
Responsible Party: Milos Popovic, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT00221117    
Other Study ID Numbers: TRI REB #02-032
First Submitted: September 14, 2005
First Posted: September 22, 2005
Results First Submitted: May 8, 2012
Results First Posted: November 20, 2017
Last Update Posted: July 24, 2018