Restoration of Upper Limb Function in Individuals With Sub-Acute Spinal Cord Injury

NCT01292811 | Terminated

• 1 other identifier: 10-048
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this research program is to conduct a multi-site clinical randomized control trial that will evaluate the efficacy of functional electrical stimulation based upper limb intervention for people with tetraplegia. This will involve recruiting 84 persons with sub-acute tetraplegia across four sites (Montreal,Toronto, Fredericton and Edmonton) and will serve to evaluate three new Canadian hand function assessments that have been specifically developed for persons with tetraplegia. Although these assessments have been recently tested and have shown considerable promise, further evaluation on their clinical utility (in particular their responsiveness and validity) is required. As well, they need to be compared with one another to determine whether any of these tests is more appropriate for clinical applications or whether further test reduction or augmentation may be required. Having measures that are sensitive and accurate in assessing hand function is key for systematically evaluating emerging therapeutic interventions.

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury; Functional Electrical Stimulation; Hand function; Tetraplegia

Outcome Measures

Primary Outcomes (1)

• Functional Independence Measure to measure burden of care

  The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population. It is viewed as the most useful tool for the assessment of progress during inpatient rehabilitation, and measures independent performance in self-care, sphincter control, transfers, locomotion, communication, and social cognition. By adding the points for each item, the possible total score ranges from 18 (lowest) to 126 (highest) level of independence

  Change from baseline at 8 weeks and at 6 month follow up

Secondary Outcomes (6)

• Graded Redefined Assessment of Strength Sensibility and Prehension to assess gross motor function and sensation of the hand

  Change from basline upon completion of therapy (8 weeks)and at 6 month follow

• Jamar® Hydraulic Hand Dynamometer to measure grip and pinch force

  Change from Baseline at 8 weeks and 6 months

• Action Research Arm Test to measure upper extremity function

  Change from Baseline at 8 weeks and 6 months

• Toronto Rehab Hand Function Test (TR-HFT)to measure gross motor hand function

  Change from Baseline at 8 weeks and 6 months

• REJOYCE

  Change from Baseline at 8 weeks and 6 months

Study Arms (2)

Functional electrical Stimulation

EXPERIMENTAL

The functional electrical stimulation for the treatment group will begin by designing a stimulation protocol that can generate the palmar and/or the lateral grasp on demand. In other words, the stimulation sequence (protocol) will be developed for each patient individually using either Compex Motion or HEWHS stimulator; this will allow the patient, who otherwise cannot grasp, to do so with the system. Both stimulators will be used to deliver the same FES therapy. Stimulation parameters are: 1) balanced, biphasic, current regulated electrical pulses; 2) pulse amplitude from 8 to 50 mA (typical values 17-26 mA); 3) pulse width from 250 to 300 μs; and 4) pulse frequency from 20 to 70 Hz (typical value 25 to 40 Hz).

Device: Functional Electrical Stimulation (Compex Motion Stimulator)

Control Group

OTHER

The Control group will receive conventional occupational therapy pertaining to hand function \[15\]. The conventional therapy represents control activities against which the FES therapy will be assessed. The conventional occupational therapy includes: 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: Conventional Occupational therapy

Interventions

Functional Electrical Stimulation (Compex Motion Stimulator) DEVICE

Functional electrical Stimulation:Parameters of stimulation: 1) balanced, biphasic, current regulated electrical pulses; 2) pulse amplitude from 8 to 50 mA (typical values 17-26 mA); 3) pulse width from250 to 300 μs; and 4) pulse frequency from 20 to 70 Hz (typical value 25 to 40 Hz).

Also known as: Functional Electrical Stimulation

Functional electrical Stimulation

Conventional Occupational therapy OTHER

The Control group will receive conventional occupational therapy pertaining to hand function \[15\]. The conventional therapy represents control activities against which the FES therapy will be assessed. The conventional occupational therapy includes: 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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sustained a traumatic incomplete SCI between C4 and C7 levels
• years of age or older
• Less than 6 months post injury
• Unable to grasp objects
• Participants must have functional biceps and deltoid muscle strength which allows them to place their hand in the working space in front of themselves, i.e., at least a grade 3 on manual muscle testing
• Participants should have a clear understanding of the goal of the study, which is to compare the FES technology to conventional occupational therapy (which may or may not enhance recovery)
• Participants should be able to read and understand and provide informed consent, and in a situation where there is a difficulty in understanding ( e.g. language barrier), have a relative or friend willing and able to accompany you to all treatment and assessment sessions, for your own safety

You may not qualify if:

• Contraindications for FES:
• cardiac pacemakers
• skin lesions, allergy, wound or rash at potential electrode sites
• denervation of targeted muscles
• pressure ulcers
• patient suffers from the cardiovascular conditions such as hypertension that is uncontrolled or autonomic dysreflexia requiring medication
• Patients on Botox therapy for their upper limb or have received Botox for the upper extremity in the last six months
• Participation in any other interventional study that may affect upper extremity function
• Participants with co existing Traumatic brain injury

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead
• Rick Hansen Foundation: collaborator
• Ontario Neurotrauma Foundation: collaborator

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, M4G 3V9, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Milos R Popovic, PhD

  Toronto Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

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: Toronto Rehab Chair in Spinal Cord Injury Research

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: February 10, 2011
• Study Start: January 1, 2011
• Primary Completion: December 3, 2014
• Study Completion: December 3, 2014
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

CA (1)