Clinical trial NCT01765153: Precision Versus Endurance Training to Improve Walking After Chronic Incomplete SCI
Official title: Precision Versus Endurance Training to Improve Walking After Chronic Incomplete SCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: physical therapy
rehabilitation
neuroplasticity
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-01-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Detailed description: PARTICIPANTS: Inclusion criteria: 1) SCI from trauma or other stable lesions, 2) injury occurred ≥ 7 mo prior, 3) able to walk independently at least 5 m with a walking aid and/or braces, 4) injury level between C1-L1, 5) able to give informed consent, 6) able to attend training sessions 5x/week. Exclusion criteria: 1) head injury, 2) cognitive or musculoskeletal impairments that preclude participation in walking training, 3) seizures or implants in the head that would preclude participation in experiments using transcranial magnetic stimulation (TMS).

INTERVENTIONS:

Precision Training. Training was performed on a 15 m long track. The track contained obstacles and targets. Obstacles were made of Styrofoam blocks of 3 cm height each, varying in width from 4 cm to 20 cm in divisions of 4 cm increments (which must be cleared without touching), and targets were made of fabric circles, ranging in diameter from 7-10.5 cm (which must be totally obscured by their foot). The difficulty of the track was designed to have the participant achieve \~80% success. The emphasis was on accuracy, not speed.

Endurance Training. The aim of this training was mass practice. Participants walked on the treadmill, with body-weight support (BWS) and manual assistance if needed. The treadmill speed was initially set to be faster than their over ground walking speed as measured by the 10 MWT(ss). Participants were encouraged to walk for as far and as fast as possible with minimal rest periods. Progression involved reducing manual assistance and BWS, increasing walking speed and distance, while reducing rest breaks.

In both phases of training, a research assistant or volunteer recorded training parameters each session. The number of steps executed was measured with a step counter (StepWatch, Orthocare Innovations, USA), which was confirmed to be accurate with simultaneous manual counting prior to its use, and periodically during training sessions. The heart rate before and immediately after each bout of walking was measured with a heart rate monitor (Polar FT7, Polar, Canada). The total time, distance and walking speed for each walking bout was recorded.

MEASURES:

Measures were taken prior to all training at baseline (called Baseline I) and the end of each of the following intervals - one month of Training Phase I, two months of Training Phase I, one month of Rest Period I, two months of Rest Period I, one month of Training Phase II, two months of Training Phase II, one month of Rest Period II, two months of Rest Period II. To measure changes during the second phase of training, the baseline was the average of the one and two month measures of Rest Period I, henceforth called Baseline II.

STATISTICAL ANALYSIS: To determined if one type of training was superior to the other, we compared the change scores (i.e., post-training score minus pre-training score) from each type of training using a standard t-test or a Mann-Whitney U test, as appropriate. Since individuals with high compared to low walking function may respond to the training differently, we divided individuals based on their pretraining walking speed as measured by the 10 MWT(ss) (i.e., \> or \< 0.5 m/s). The change scores from each of these groups of individuals were then compared for each type of training using a standard t-test or a Mann-Whitney U test, as appropriate. To determine the time course for obtaining a treatment effect, we compared the change scores for the first month (i.e., outcome measure at end of 1 mo minus baseline) versus the second month (outcome measure at end of 2 mo minus at end of 1 mo) of training for each type of training, using a standard t-test or a Mann-Whitney U test, as appropriate. Retention of gains was followed for 2 months after each type of training. The outcome measures at the end of the 2 month rest period were compared to the measures immediately after the training, for individuals that made improvements greater than the standard error of measurement for each measure, using a paired t-test or Wilcoxon signed-rank test, as appropriate.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at Completion of Study
timeFrame: 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:
measure: Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase I
timeFrame: Change from Baseline I to 2 months of Training Phase I
measure: Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period I
timeFrame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
measure: Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase II
timeFrame: Change from Baseline II to 2 months of Training Phase II
measure: Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period II
timeFrame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
measure: Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase I
timeFrame: Change from Baseline I to 2 months of Training Phase I
measure: Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period I
timeFrame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
measure: Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase II
timeFrame: Change from Baseline II to 2 months of Training Phase II
measure: Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period II
timeFrame: Change from the end of Phase II training to 2 months of Rest Period II
measure: Change in 10 Metre Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase I
timeFrame: Change from Baseline I to 2 months of Training Phase I
measure: Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period I
timeFrame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
measure: Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase II
timeFrame: Change from Baseline II to 2 months of Training Phase II
measure: Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period II
timeFrame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
measure: Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase I
timeFrame: Change from Baseline I to 2 months of Training Phase I
measure: Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period I
timeFrame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
measure: Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase II
timeFrame: Change from Baseline II to 2 months of Training Phase II
measure: Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period II
timeFrame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
measure: Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase I
timeFrame: Change from Baseline I to 2 months of Training Phase I
measure: Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period I
timeFrame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
measure: Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase II
timeFrame: Change from Baseline II to 2 months of Training Phase II
measure: Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period II
timeFrame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
measure: Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase I
timeFrame: Change from Baseline I to 2 months of Training Phase I
measure: Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period I
timeFrame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
measure: Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase II
timeFrame: Change from Baseline II to 2 months of Training Phase II
measure: Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period II
timeFrame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
measure: Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase I
timeFrame: Change from Baseline I to 2 months of Training Phase I
measure: Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period I
timeFrame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
measure: Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase II
timeFrame: Change from Baseline II to 2 months of Training Phase II
measure: Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period II
timeFrame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
measure: Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase I
timeFrame: Change from Baseline I to 2 months of Training Phase I
measure: Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period I
timeFrame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
measure: Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase II
timeFrame: Change from Baseline II to 2 months of Training Phase II
measure: Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period II
timeFrame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
measure: Change in Manual Muscle Test (MMT) at 2 Months of Training Phase I
timeFrame: Change from Baseline I to 2 months of Training Phase I
measure: Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period I
timeFrame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
measure: Change in Manual Muscle Test (MMT) at 2 Months of Training Phase II
timeFrame: Change from Baseline II to 2 months of Training Phase II
measure: Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period II
timeFrame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
measure: Change in Cutaneomuscular Reflexes at 2 Months of Training Phase I
timeFrame: Change from Baseline I to 2 months of Training Phase I
measure: Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period I
timeFrame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
measure: Change in Cutaneomuscular Reflexes at 2 Months of Training Phase II
timeFrame: Change from Baseline II to 2 months of Training Phase II
measure: Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period II
timeFrame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
measure: Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase I
timeFrame: Change from Baseline I to 2 months of Training Phase I
measure: Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period I
timeFrame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
measure: Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase II
timeFrame: Change from Baseline II to 2 months of Training Phase II
measure: Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period II
timeFrame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
measure: Change in Electromyography During Treadmill Walking at 2 Months of Training Phase I
timeFrame: Change from Baseline I to 2 months of Training Phase I
measure: Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period I
timeFrame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
measure: Change in Electromyography During Treadmill Walking at 2 Months of Training Phase II
timeFrame: Change from Baseline II to 2 months of Training Phase II
measure: Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period II
timeFrame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Jaynie Yang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Monica Gorassini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.