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

NCT00221117 | Completed Results DMC

• 1 other identifier: TRI REB #02-032
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Functional Independence Measure (FIM)

  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.

  35 min

Secondary Outcomes (2)

• Rehabilitation Engineering Laboratory Hand Function Test(REL Test)

  45 min

• Spinal Cord Independence Measure (SCIM).

  30 min

Study Arms (2)

Conventional Occupational Therapy (COT)

ACTIVE COMPARATOR

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.

Other: Conventional Ocupational Therapy (COT)

Neuroprosthesis-FES Therapy

EXPERIMENTAL

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.

Device: Neuroprosthesis-FES Therapy

Interventions

Neuroprosthesis-FES Therapy DEVICE

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.

Also known as: Neuroprosthesis

Neuroprosthesis-FES Therapy

Conventional Ocupational Therapy (COT) OTHER

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.

Also known as: Conventional Occupational Therapy (COT)

Conventional Occupational Therapy (COT)

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(incomplete)
• participants will be recruited during the first six months post-SCI.

You may not qualify if:

• uncontrolled hypertension
• susceptibility to autonomic dysreflexia
• pressure ulcer
• cardiac pacemakers
• skin rush

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead
• Christopher Reeve Paralysis Foundation: collaborator
• The Physicians' Services Incorporated Foundation: collaborator

Related Publications (2)

• 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. doi: 10.1038/sj.sc.3101191.

  PMID: 11512070 BACKGROUND

• 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.

  PMID: 24968955 DERIVED

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

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.

Results Point of Contact

• Title: Dr. Milos Popovic
• Organization: Toronto RI Institute

milos.popovic@utoronto.ca

416-597-3422

Study Officials

• Milos Popovic, Ph.D

  University of Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 24, 2018
• Results First Posted: November 20, 2017

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share