N/A
N=21
Precision Versus Endurance Training to Improve Walking After Chronic Incomplete SCI
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT01765153 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at Completion of Study — -128.77; -64.07 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endurance (Behavioral); Precision (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alberta
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at Completion of Study |
-128.77; -64.07 | — |
| SECONDARY Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase I |
-129.09; -69.51 | — |
| SECONDARY Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period I |
-1.04; 10.34 | — |
| SECONDARY Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase II |
-15.28; -13.35 | 0.04366667 sig |
| SECONDARY Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period II |
1.61; 16.10 | — |
| SECONDARY Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase I |
32.75; 17.43 | — |
| SECONDARY Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period I |
6.78; 32.23 | — |
| SECONDARY Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase II |
3.9; 25.78 | — |
| SECONDARY Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period II |
-14.63; 17.00 | — |
| SECONDARY Change in 10 Metre Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase I |
0.07; 0.06 | — |
| SECONDARY Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period I |
0.04; 0.09 | — |
| SECONDARY Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase II |
0.02; 0.06 | — |
| SECONDARY Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period II |
-0.02; -0.09 | — |
| SECONDARY Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase I |
0.07; 0.21 | — |
| SECONDARY Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period I |
0.04; 0.14 | — |
| SECONDARY Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase II |
0.06; 0.09 | — |
| SECONDARY Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period II |
-0.09; 0.12 | — |
| SECONDARY Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase I |
0.32; 1.30 | — |
| SECONDARY 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 |
-0.22; -0.22 | — |
| SECONDARY Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase II |
0.50; 0 | — |
| SECONDARY 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 |
0; 0 | — |
| SECONDARY Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase I |
0.73; 1.63 | — |
| SECONDARY Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period I |
-0.25; -0.19 | — |
| SECONDARY Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase II |
0.22; 0.44 | — |
| SECONDARY Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period II |
0.00; -0.50 | — |
| SECONDARY Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase I |
4.15; 3.15 | — |
| SECONDARY Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period I |
0.38; 1.70 | — |
| SECONDARY Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase II |
3.78; 6.48 | — |
| SECONDARY Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period II |
-0.08; -0.63 | — |
| SECONDARY Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase I |
-3.85; -2.42 | — |
| SECONDARY Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period I |
0.61; -0.64 | — |
| SECONDARY Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase II |
-2.75; -0.53 | — |
| SECONDARY Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period II |
3.25; -0.25 | — |
| SECONDARY Change in Manual Muscle Test (MMT) at 2 Months of Training Phase I |
1.29; 2.50 | — |
| SECONDARY Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period I |
-2.45; -1.06 | — |
| SECONDARY Change in Manual Muscle Test (MMT) at 2 Months of Training Phase II |
1.22; 0.56 | — |
| SECONDARY Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period II |
-3.00; 0.07 | — |
| SECONDARY Change in Cutaneomuscular Reflexes at 2 Months of Training Phase I |
-6.84; 2.36 | — |
| SECONDARY Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period I |
0.18; 4.35 | — |
| SECONDARY Change in Cutaneomuscular Reflexes at 2 Months of Training Phase II |
3.01; -5.97 | — |
| SECONDARY Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period II |
2.13; 1.82 | — |
| SECONDARY Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase I |
122.9; 113.9 | — |
| SECONDARY Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period I |
115.1; 121.7 | — |
| SECONDARY Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase II |
124.3; 111.0 | — |
| SECONDARY Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period II |
141.0; 111.6 | — |
| SECONDARY Change in Electromyography During Treadmill Walking at 2 Months of Training Phase I |
0.28; 0.14 | — |
| SECONDARY Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period I |
1.04; 0.38 | — |
| SECONDARY Change in Electromyography During Treadmill Walking at 2 Months of Training Phase II |
0.73; -0.26 | — |
| SECONDARY Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period II |
0.53; 0.63 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT01765153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.