Reactive Stepping Training in Individuals With Spinal Cord Injury

NCT02960178 | Completed

• 1 other identifier: 16-5685-DE
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Falling is common among individuals with incomplete spinal cord injury (iSCI), with most falls occurring while walking. Falls result in injuries (e.g., broken bones), hospital readmission, and reduced participation in work and recreation. In able-bodied people, falls can be prevented by taking one or more rapid, reactive steps. People with iSCI, however, have difficulty taking the reactive steps needed to prevent a fall. Research in the elderly and people with stroke has shown that repetitive training of reactive steps in a safe environment improves this balance reaction and prevents falls. The investigators will examine the feasibility and effectiveness of reactive step training in people with iSCI. The main objective is to determine if reactive balance training leads to greater improvements in balance reactions, scores on clinical scales, and fall rates compared with conventional walking training. A three year, pilot randomized clinical trial (RCT) will be completed. By improving balance and reducing falls, people with iSCI will experience fewer complications (e.g., injuries), and greater recovery of function and community participation.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Change in reactive stepping ability (Lean and Release Test)

  Inness EL, Mansfield A, Biasin L, et al. Clinical implementation of a reactive balance control assessment in a sub-acute stroke patient population using a 'lean-and-release' methodology. Gait \& Posture 2015; 41: 529-34.

  Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training

Secondary Outcomes (5)

• Change in the Mini-BESTest score

  Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training

• Change in the Activities-specific Balance Confidence Scale score

  Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training

• Change in the Community Balance & Mobility Scale

  Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training

• Change in spatiotemporal measures of gait

  Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training

• Change in the Falls Efficacy Scale - International score

  Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training

Study Arms (2)

Perturbation-based training

EXPERIMENTAL

Participants will practice standing and walking activities while secured in an overhead harness attached to an overhead track. While practicing these tasks, the trainer will apply pushes and pulls to the harness at unexpected times, causing a reactive step to be practiced.

Behavioral: Perturbation-based training

Conventional walking training

ACTIVE COMPARATOR

Participants will practice standing and walking activities while secured in an overhead harness attached to an overhead track. No external perturbations will be applied.

Behavioral: Conventional walking training

Interventions

Perturbation-based training BEHAVIORAL

Over-ground practice of stepping and balance tasks in standing with perturbations applied by the trainer (pushes and pulls to the safety harness). One hour in duration with 60 perturbations targeted per hour.

Perturbation-based training

Conventional walking training BEHAVIORAL

Over-ground practice of stepping and balance tasks in standing. One hour in duration.

Conventional walking training

Eligibility Criteria

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

You may qualify if:

• individuals with SCI rated as C or D on the American Spinal Injury Association Impairment Scale (AIS)
• chronic SCI (i.e., \>1 year post-injury)
• a traumatic or non-traumatic and non-progressive cause of SCI
• ≥18 years old
• able to stand for 30s unsupported
• moderate level of trunk control as evidenced by the ability to reach forward \>2 inches with the outstretched arm in standing (i.e., score of 2 on Berg Balance Scale Reaching Forward Task
• free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke)
• no known, untreated orthostatic hypotension, hypertension, or atrial/ventricular arrhythmia

You may not qualify if:

• severe spasticity in the legs
• contractures in the lower extremity that prevent achieving a neutral hip and ankle position, or extended knee
• a pressure sore (\>grade 2) on the pelvis or trunk where the harness will be applied
• a prior lower extremity fragility fracture.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Ontario Neurotrauma Foundation: collaborator

Study Sites (1)

Lyndhurst Centre, Toronto Rehabilitation Institute-UHN

Toronto, Ontario, M4G 3V9, Canada

Location

Related Publications (3)

• Heffernan MG, Lee JW, Chan K, Unger J, Marzolini S, Welsh TN, Masani K, Musselman KE. Spatial characteristics of reactive stepping among people living with chronic incomplete spinal cord injury. J Spinal Cord Med. 2023 Sep;46(5):769-777. doi: 10.1080/10790268.2023.2175575. Epub 2023 Apr 10.

  PMID: 37037014 DERIVED

• Unger J, Chan K, Lee JW, Craven BC, Mansfield A, Alavinia M, Masani K, Musselman KE. The Effect of Perturbation-Based Balance Training and Conventional Intensive Balance Training on Reactive Stepping Ability in Individuals With Incomplete Spinal Cord Injury or Disease: A Randomized Clinical Trial. Front Neurol. 2021 Feb 2;12:620367. doi: 10.3389/fneur.2021.620367. eCollection 2021.

  PMID: 33603710 DERIVED

• Unger J, Oates AR, Lanovaz J, Chan K, Lee JW, Theventhiran P, Masani K, Musselman KE. The measurement properties of the Lean-and-Release test in people with incomplete spinal cord injury or disease. J Spinal Cord Med. 2022 May;45(3):426-435. doi: 10.1080/10790268.2020.1847562. Epub 2020 Dec 2.

  PMID: 33263499 DERIVED

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 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: Scientist

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 9, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)