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N/A N=21 Randomized Single-blind Treatment

Precision Versus Endurance Training to Improve Walking After Chronic Incomplete SCI

Spinal Cord Injury

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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