Combined Tactile and Proprioception Training After Spinal Cord Injury

NCT02554058 | Completed DMC

• 1 other identifier: Bannatyne2010:157
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A novel rehabilitation bike has been developed for patients with incomplete spinal cord injuries that incorporates mechanical stimulators on the bike pedals to stimulate the sensory receptors in the soles of the feet; the effect of mechanical stimulator on muscle strengthening has been reported by NASA to improve muscle atrophy in astronauts in zero-gravity environments. Cycling also stimulates lower limb position sensors. We predict that the combination of mechanical stimulation with cycling may be similar enough to walking over ground to lead to gains in balance and mobility. The present study will evaluate the therapeutic effect of this bike on balance, walking, as well as cortical-spinal and spinal pathways in patients with incomplete spinal cord injuries.

Conditions

Spinal Cord Injury

Keywords

Spinal cord injury; rehabilitation; cycling

Outcome Measures

Primary Outcomes (2)

• Change in Peak-to-peak amplitude of the motor evoked potentials (MEPs)

  MEPs in tibialis anterior muscle using single pulse transcranial magnetic stimulation will be measure.The average of 4 trials in different stimulation intensity will be calculated.

  2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session

• Change in Peak-to-peak amplitude of the H-reflex

  Average of 10 peak to peak amplitudes of the H-reflex in soleus muscle with stimulation frequencies of 0.1, 0.2, 0.5 and 10 Hz.

  2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session

Secondary Outcomes (4)

• Change in Berg Balance Scale score(BBS)

  2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session

• Change in 10 meter walk test time

  2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session

• Change in 2 minute walk test score

  2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session

• Change in Walking index for spinal cord injury (WISCI II) score

  2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session

Other Outcomes (1)

• Change in Modified Ashworth Scale score

  2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training

Study Arms (1)

Cycling and Mechanical stimulation

EXPERIMENTAL

Cycling and Mechanical stimulation : 30 minute cycling training, 3 times a week for 8 weeks.

Device: Cycling and Mechanical stimulation

Interventions

Cycling and Mechanical stimulation DEVICE

Cycling and Mechanical stimulation : 30 minute cycling training, 3 times a week for 8 weeks.

Cycling and Mechanical stimulation

Eligibility Criteria

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

You may qualify if:

• The participant should have experienced a traumatic spinal cord injury
• American Spinal Injury Association (ASIA) class C or D
• Between 18 and 65 years
• At least 12 months post- injury to ensure stability of the patient's neurological condition
• Should be able to walk 10 meters or more with or without assistance (use of braces or walking aids or parallel bars or moderate assistance of one person)
• Should have range of motion in the lower limb joint sufficient to allow the cycling exercise
• Discharged from all rehabilitation.

You may not qualify if:

• Impaired mental capacity
• Any medical contradiction to cycling training
• Degenerative spinal disorder
• Significant diagnosed osteoporosis
• Excessive spasticity in the legs as measured by a score of more than 3 on the Modified Ashworth Scale or any spasticity that limits the possibility of cycling exercise or walking
• Obstructive and/or restrictive pulmonary disease
• Severe spinal and Lower Limb deformities
• Decubitus ulcer in the area in contact with the bike and bike's bed

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Rehab/Resp Hospital (Health Sciences Center)

Winnipeg, Manitoba, Canada

Location

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

Study Officials

• Chery Glazebrook

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 18, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

CA (1)