Trial Outcomes & Findings for Benefits of Applying Neuroprosthesis to Improve Grasping and Reaching in Spinal Cord Injury Patients (NCT NCT00221117)
NCT ID: NCT00221117
Last Updated: 2018-07-24
Results Overview
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.
COMPLETED
NA
22 participants
35 min
2018-07-24
Participant Flow
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.
If participant did not meet inclusion criteria they would be excluded
Participant milestones
| Measure |
Conventional Occupational Therapy-Control Group
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.
|
Fes Therapy-Treatment Group
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
|
Overall Study
COMPLETED
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Benefits of Applying Neuroprosthesis to Improve Grasping and Reaching in Spinal Cord Injury Patients
Baseline characteristics by cohort
| Measure |
Conventional Occupational Therapy-Control Group
n=12 Participants
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.
|
Fes Therapy-Treatment Group
n=9 Participants
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
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
44.75 years
STANDARD_DEVIATION 4.72 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 5.45 • n=7 Participants
|
43.975 years
STANDARD_DEVIATION 5.085 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 35 minFunctional 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.
Outcome measures
| Measure |
FES Therapy
n=9 Participants
The Functional Independence Measure (FIM)15 was employed to measure the degree of disability for daily self-care.
|
Conventional Occupational Therapy
n=12 Participants
The Functional Independence Measure (FIM)15 was employed to measure the degree of disability for daily self-care.
|
|---|---|---|
|
Functional Independence Measure (FIM)
|
20.1 units on a scale
Standard Deviation 9.87
|
10 units on a scale
Standard Deviation 9.065
|
SECONDARY outcome
Timeframe: 45 minPopulation: The subject's impairment and demographic characteristics were analyzed using descriptive statistics for parametric and nonparametric data.
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.
Outcome measures
| Measure |
FES Therapy
n=9 Participants
The Functional Independence Measure (FIM)15 was employed to measure the degree of disability for daily self-care.
|
Conventional Occupational Therapy
n=12 Participants
The Functional Independence Measure (FIM)15 was employed to measure the degree of disability for daily self-care.
|
|---|---|---|
|
Rehabilitation Engineering Laboratory Hand Function Test(REL Test)
|
16.7 units on a scale
Standard Deviation 14.80
|
11.3 units on a scale
Standard Deviation 9.52
|
SECONDARY outcome
Timeframe: 30 minScore range from 0-100. Higher score represent a better outcome.
Outcome measures
| Measure |
FES Therapy
n=9 Participants
The Functional Independence Measure (FIM)15 was employed to measure the degree of disability for daily self-care.
|
Conventional Occupational Therapy
n=12 Participants
The Functional Independence Measure (FIM)15 was employed to measure the degree of disability for daily self-care.
|
|---|---|---|
|
Spinal Cord Independence Measure (SCIM).
|
10.1 units on a scale
Standard Deviation 3.8
|
3.1 units on a scale
Standard Deviation 2.4
|
Adverse Events
Control Group
Fes Therapy-Treatment Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place