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

• 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: Toronto Rehabilitation Institute
• 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

Participant Flow

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
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.

Baseline Characteristics

Arm/Group Title		Conventional Occupational Therapy-Control Group	Fes Therapy-Treatment Group	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Functional Independence Measure (FIM)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FES Therapy	Conventional Occupational Therapy
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)

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)
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

Outcome Measure Data

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
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)

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).
Description	Score range from 0-100. Higher score represent a better outcome.
Time Frame	30 min

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FES Therapy	Conventional Occupational Therapy
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Control Group	Fes Therapy-Treatment Group
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	--/--	--/--
Serious Adverse Events
	Control Group	Fes Therapy-Treatment Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/12 (0.00%)	0/9 (0.00%)
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%)

Limitations and Caveats

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.

More Information

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

• Name/Title: Dr. Milos Popovic
• Organization: Toronto RI Institute
• Phone: 416-597-3422 ext 6305
• EMail: milos.popovic@utoronto.ca

Publications:

Popovic MR, Curt A, Keller T, Dietz V. Functional electrical stimulation for grasping and walking: indications and limitations. Spinal Cord. 2001 Aug;39(8):403-12. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kapadia NM, Bagher S, Popovic MR. Influence of different rehabilitation therapy models on patient outcomes: hand function therapy in individuals with incomplete SCI. J Spinal Cord Med. 2014 Nov;37(6):734-43. doi: 10.1179/2045772314Y.0000000203. Epub 2014 Jun 26.

• 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