Restorative Neuromodulation for Lower Extremity Functions

NCT04171375 | Completed

• 1 other identifier: HSEARS20190201002
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of the proposed study is to restore lower-extremity functions of paraplegic individuals. Paralysis following Stroke or spinal cord injury (SCI) result harsh sufferings including lifelong dependence on wheelchairs and thus often life threatening conditions such as pressure sore resulted from the immobility. Recently, electrical stimulation targeting the lumbosacral spinal cord has shown activation of spinal circuits that control standing and walking functions; while body-weight supported locomotor training has shown overall health improvement of the paraplegic patients through activity dependent rehabilitation. In the current project we aim to combine the trans-spinal electrical stimulation and locomotor training in an efficient, cost-effective and simplified manner for functional rehabilitation. In this proposed study, Stroke and SCI paraplegics will be regularly trained to stand and walk on a body-weight support system with the aid of lower-limb orthoses and trans-spinal electrical stimulation. In progressive weeks the orthotic support of the lower-limb would be slowly lifted off and only the stimulation therapy will be delivered during the locomotor training. Repetitive training with this combination therapy, the spinal pathways would likely reorganize and would promote long-term rehabilitation of the lower-extremity. After successful demonstration of this in our laboratory settings, we aim to transform this technology for community use.

Conditions

Spinal Cord Injuries; Stroke; Paralysis

Outcome Measures

Primary Outcomes (4)

• American Spinal Injury Association Impairment Scale

  An experienced physiotherapist will assess the patient at baseline and every month until the end of the study. The physiotherapist will use the American Spinal Injury Association Impairment Scale, a maximum possible score is 112 points to evaluate the sensation and muscle strengths of the patient. In particular, the examinations will involve manual muscle testing (with grades 0 to 5\*; higher grades indicate stronger muscle strength), anorectal examination, as well as assessments of light touch (using a piece of cotton) and pinprick sensation (using a paper clip). All assessments will follow the myotome and dermatome. Based on the findings, an American Spinal Injury Association Impairment Scale grade will be given to indicate the severity of paralysis.

  18 months

• Modified Ashworth Scale

  The spasticity of the patient was evaluated by the Modified Ashworth Scale, which is a 6-point scale to assess the resistance experienced by the therapist during passive muscle stretching. Higher scores indicate greater spasticity.

  18 months

• Neuromuscular Recovery Scale

  The neuromuscular recovery scale will be used to quantify functionally motor tasks without compensation. It consists of 14 items/tasks (e.g., sit-to-stand, or standing). The physiotherapist will rate each item by comparing the deviations of patients' performance from the normative task performance in the movement pattern. Lower scores indicate major deviations. The maximum sum of all item scores is 161.

  18 months

• Spinal Cord Independence Measure

  The functional performance of the patient will be assessed by the Spinal Cord Independence Measure. This is an observational examination contains three subscales with a maximum score of 100: (1) self-care; (2) respiration and sphincter; and (3) mobility. The self-care subscale includes six tasks (with a score ranging from 0 to 20). The respiration and sphincter subscale includes four tasks (with a score ranging from 0 to 40). The mobility subscale (with a score ranging from 0 to 40) contains two more subscales to evaluate mobility in "room and toilet", and "indoors and outdoors, on even surface". A higher score indicates a better function.

  18 months

Secondary Outcomes (1)

• 5-10 meter overground walking test

  12 months

Other Outcomes (1)

• Electrophysiology

  18 months

Study Arms (1)

trans-spinal Electrical Stimulation (tsES)

EXPERIMENTAL

Device: trans-spinal Electrical Stimulation (tsES)

Interventions

trans-spinal Electrical Stimulation (tsES) DEVICE

The trans-spinal pulsed-current stimulation utilizes non-invasive russian stimulation using a research grade stimulator and direct-current stimulation utilizes non-invasive constant stimulation using a medical grade stimulator. Both pulsed- and direct-current stimulation will be achieved with cutaneous cathode electrodes attached to the dorsal aspect of the back overlying at and bellow thoracic vertebrae and anode electrodes placed over the iliac crests or lower abdomen. Spinal motor evoked potentials will be induced by trans-spinal pulsed-current stimulation (parameters, 1 Hz with a 1 millisecond pulse width and monophasic waveform) to determine recruitment profiles of proximal and distal motor pools with increasing stimulation intensity ranging from 10-200 milliampere. Stimulation parameters for the therapeutic stimulation will be ranged from 5-50 Hz and 20-200 milliampere. For direct-current stimulation, the stimulation current will be kept constant at 2-2.5 milliampere.

trans-spinal Electrical Stimulation (tsES)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be at least one year post-injury and not dependent on ventilation support
• Lower-extremity paralyzed and half of key muscles below neurological level having a motor score of less than 2/5
• Female subjects must be on standard contraception method and must not be pregnant throughout the study
• Segmental reflexes are functional below the lesion
• Ability to exercises 1-2 hours per day and commit for 1 year training program

You may not qualify if:

• Cardiopulmonary disease or dysfunction, high blood pressure or other condition which contraindicate participation in lower extremity rehabilitation exercise
• Received of Botox injections in the prior 6 months
• Weakened bone, unhealed fracture, contracture, pressure sore, or infection that might interfere with the exercise
• Thoracic or lumbar fusion with any metal which may interfere with electric currents
• Other electronic implants such as cardiac pacemaker, defibrillator, shunt, stent etc.
• Currently receiving treatments for pain management or spasticity or depression.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• University of California, Los Angeles: collaborator
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

Department of Biomedical Engineering, The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Stroke; Paralysis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Monzurul Alam, PhD

  Research Assistant Professor

  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: Research Assistant Professor

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: November 20, 2019
• Study Start: April 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: November 30, 2021
• Last Updated: January 6, 2022

Record last verified: 2022-01

Locations

HK (1)