Precision Versus Endurance Training to Improve Walking After Chronic Incomplete SCI

NCT01765153 | Completed Results DMC

• 1 other identifier: Pro00003873
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study was to determine the efficacy of two forms of physical therapy training, one emphasizing precise, visually guided walking over obstacles and on targets (Precision Training), the other emphasizing mass practice of walking on a treadmill (Endurance Training). The hypothesis was that visually guided training (Precision) may be especially efficacious because it engages the motor cortex, whose input may facilitate improvements in functional walking. Participants are individuals with a chronic (≥7 months post-injury), motor incomplete spinal cord injury (SCI), with no other problems that would preclude participation in an intensive training program. A randomized, single-blinded, cross-over design was used to randomly allocate participants to start with Precision or Endurance Training, identified as Training Phase I. Training was 5x/wk for 2 months, followed by a 2-month rest period, identified as Rest Period I. Participants then returned for 2-months of training in the other method, identified as Training Phase II, followed by another 2-month rest, Rest Period II. Measures of walking speed, distance, skill, confidence, as well as depression were obtained at least 3 times before any training, then monthly thereafter. Electrophysiological measures were taken before and after each phase of training and period of rest. Change scores were used to determine how each phase of training and rest influenced the scores (see below).

Conditions

Spinal Cord Injury

Keywords

physical therapy; rehabilitation; neuroplasticity

Outcome Measures

Primary Outcomes (1)

• Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at Completion of Study

  This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.

  Change from Baseline I to the end of the study (i.e., end of Rest Period II, which was ~8 months after the beginning of the study)

Secondary Outcomes (48)

• Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase I

  Change from Baseline I to 2 months of Training Phase I

• Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period I

  Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I

• Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase II

  Change from Baseline II to 2 months of Training Phase II

• Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period II

  Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II

• Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase I

  Change from Baseline I to 2 months of Training Phase I

Study Arms (2)

Endurance first

EXPERIMENTAL

Participants to start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training was 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest. Measures of walking speed, distance, skill, confidence, as well as mood were obtained at least 3 times before any training, then monthly thereafter.

Behavioral: Endurance; Behavioral: Precision

Precision first

EXPERIMENTAL

Participants to start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training was 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest. Measures of walking speed, distance, skill, confidence, as well as mood were obtained at least 3 times before any training, then monthly thereafter.

Behavioral: Endurance; Behavioral: Precision

Interventions

Endurance BEHAVIORAL

Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training.

Also known as: Treadmill walking training, Body-weight supported treadmill training

Endurance first; Precision first

Precision BEHAVIORAL

Participants train daily to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto.

Also known as: Skill walking training

Endurance first; Precision first

Eligibility Criteria

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

You may qualify if:

• spinal cord injury equal or more than 7 months prior
• able to walk at least 5 meters independently (can use walking aids and braces)
• injury level between C1 and L1
• able to give informed consent
• able to attend training sessions 5x/week

You may not qualify if:

• head injury
• cognitive of musculoskeletal impairments that preclude participation in walking training
• seizures or implants in the head that would preclude participation in experiments with transcranial magnetic stimulation

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

Location

Related Publications (2)

• Khan AS, Patrick SK, Roy FD, Gorassini MA, Yang JF. Training-Specific Neural Plasticity in Spinal Reflexes after Incomplete Spinal Cord Injury. Neural Plast. 2016;2016:6718763. doi: 10.1155/2016/6718763. Epub 2016 Sep 20.

  PMID: 27725887 DERIVED

• Musselman KE, Yang JF. Spinal Cord Injury Functional Ambulation Profile: a preliminary look at responsiveness. Phys Ther. 2014 Feb;94(2):240-50. doi: 10.2522/ptj.20130071. Epub 2013 Oct 10.

  PMID: 24114437 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

Limitations and Caveats

* Participants were a sample of convenience, likely the most highly motivated due to the time commitment. * Sample size was small. * 4 participants were less than 1 year post injury and may have had spontaneous recovery.

Results Point of Contact

• Title: Dr. Jaynie Yang
• Organization: University of Alberta

jaynie.yang@ualberta.ca

780-492-2894

Study Officials

• Jaynie Yang, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Monica Gorassini, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: January 10, 2013
• Study Start: March 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 2, 2017
• Results First Posted: May 2, 2017

Record last verified: 2017-01

Locations

CA (1)