Task-specificity for Locomotor Recovery Following SCI

NCT03144388 | Completed

• 1 other identifier: IU1705279110
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of the proposed study is to identify the contributions of the amount of task-specific practice on locomotor (i.e., walking) recovery in patients with chronic (\> 1 yr) motor incomplete spinal cord injury (iSCI). Consistent with principles of motor learning and exercise physiology, the investigators contend that certain training (i.e., dosage) parameters of physical rehabilitation are critical to mobility outcomes following neurological injury. Specifically, the specificity, amount and intensity of physical interventions (i.e., practice) may influence specific outcomes in the patient population treated. In ambulatory patients with iSCI, there are very few studies that have controlled for or targeted these training variables or their influence on locomotor recovery. Previous work suggests these training parameters may influence locomotor recovery in patients with other neurological disorders (i.e., stroke), although few studies have attempted to delineate similar contributions of in iSCI. Indeed, no studies have carefully controlled the amount of task-specific practice during physical rehabilitation of patients with iSCI, and such interventions are rarely utilized in the clinical setting. The goal of the present study is to delineate the relative contributions of amount of task-specific training on locomotor outcomes in individuals with iSCI. Using a cross-over, randomized clinical trial design, the investigators anticipated non-specific (i.e., non-stepping) training activities would result in smaller improvements as compared to task-specific (stepping) training. The investigators will investigate the effects of such training on walking performance and kinematics, as well as the impairments thought to contribute to walking performance. Successful completion of this project could have an immediate impact on rehabilitation research and treatment of people following iSCI, and may be utilized to treat more subacute patients with iSCI or other acute-onset neurological disorders.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Walking Speed

  fastest comfortable walking speed over short distances

  change in walking speed from baseline testing to post-testing following 6 weeks of training

Secondary Outcomes (1)

• Walking Distance

  change in walking speed from baseline testing to post-testing following 6 weeks of training

Study Arms (2)

Variable Stepping Training

EXPERIMENTAL

High intensity stepping training in multiple environments, including overground, on a treadmill and on stairs.

Procedure: Variable Stepping Training

Variable Non-specific Training

ACTIVE COMPARATOR

High intensity non-stepping training, including balance, strength, and cycling tasks

Procedure: Variable Non-specific Training

Interventions

Variable Stepping Training PROCEDURE

Six weeks (20 sessions) of high intensity stepping training in multiple variable environments

Variable Stepping Training

Variable Non-specific Training PROCEDURE

Six weeks (20 sessions) of high intensity stepping training in multiple variable environments

Variable Non-specific Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals with chronic (\>1 yr duration) motor iSCI at the level or T10 (anatomical) or above
• ages 18-75 years
• ability to walk without physical assistance but with below-knee braces and assistive devices as needed
• self-selected gait speeds between 0.01-1.0 m/s.
• not currently receiving physical therapy

You may not qualify if:

• uncontrolled cardiopulmonary or metabolic disease that limits exercise participation
• active heterotopic ossification
• recurrent history of lower extremity fractures
• previous orthopedic or other peripheral or central neurological injury that may impair locomotor function
• history of botulinum toxin injection \< 3 months prior
• Patients who are prescribed intrathecal or oral anti-spastics should agree to limit changes in anti-spastic use throughout the training and testing period.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254-2607, United States

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

• Thomas Hornby

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessors at each measurement
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel-group with optional crossover

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 8, 2017
• Study Start: July 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: September 30, 2020
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)