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Enhancing Walking in People With Incomplete Spinal Cord Injury: a Pilot Study

Primary Purpose

Motor-incomplete Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Body-weight supported treadmill training
Body-weight supported treadmill training
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motor-incomplete Spinal Cord Injury focused on measuring Spinal cord injury, walking, gait training, body-weight supported treadmill training, rehabilitation

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. motor-incomplete SCI due to non-progressive lesion (e.g. trauma, ischemia) at least 12 months ago
  2. 19 to 65 years of age
  3. use of standing or walking as part of typical activities of daily living
  4. controlled spasticity (stable administration of anti-spasticity medication) for the duration of the study

Exclusion Criteria:

  1. lesion below 11th thoracic level (lower motoneuron injury)
  2. weight greater than 300 lbs or height greater than 6'1"
  3. femur length <35 cm or >47 cm and body weight >150 kg
  4. cardiac, musculoskeletal, or other uncontrolled health condition (e.g. orthostatic hypotension, osteoporosis) for which exercise or treadmill activity is contra-indicated
  5. existing skin irritation or open wounds/sores in lower extremity areas in contact with the leg cuffs of the Lokomat or body weight support harness
  6. existing cognitive impairment (as indicated by a Cognitive Capacity Screening Examination (CCSE) score of less than 24 out of 30)
  7. participation in rehabilitation therapy or other research study with exercise or mobility outcomes

Sites / Locations

  • Human Locomotion Lab, University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

One of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to leg movements while walking.

One of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to leg movements while walking.

Outcomes

Primary Outcome Measures

The primary outcome is functional ambulation measured before, after, 1-month after, and 6-months after training.

Secondary Outcome Measures

Average activity level per day measured before, after, 1-month after, and 6-months after training

Full Information

First Posted
January 28, 2008
Last Updated
September 24, 2014
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00610974
Brief Title
Enhancing Walking in People With Incomplete Spinal Cord Injury: a Pilot Study
Official Title
Enhancing Walking in People With Incomplete Spinal Cord Injury by Improving Swing Phase Activity: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The research proposed here will determine the effect of a novel treadmill gait training strategy using a robotic gait trainer (the Lokomat) on functional ambulation in people with SCI. The effect of the new therapy will be evaluated by analyzing changes in functional ambulation and gait patterns during walking.
Detailed Description
Community-dwelling individuals with motor-incomplete spinal cord injury will be recruited. In total, 20 participants will be recruited and randomly assigned to one of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to the leg movements while walking. Therapy for both groups will take place 3 times/week for 12 weeks. During each session, participants will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but participants should complete 45 minutes of walking per session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motor-incomplete Spinal Cord Injury
Keywords
Spinal cord injury, walking, gait training, body-weight supported treadmill training, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
One of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to leg movements while walking.
Arm Title
2
Arm Type
Experimental
Arm Description
One of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to leg movements while walking.
Intervention Type
Behavioral
Intervention Name(s)
Body-weight supported treadmill training
Intervention Description
BWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session.
Intervention Type
Behavioral
Intervention Name(s)
Body-weight supported treadmill training
Intervention Description
BWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session.
Primary Outcome Measure Information:
Title
The primary outcome is functional ambulation measured before, after, 1-month after, and 6-months after training.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Average activity level per day measured before, after, 1-month after, and 6-months after training
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: motor-incomplete SCI due to non-progressive lesion (e.g. trauma, ischemia) at least 12 months ago 19 to 65 years of age use of standing or walking as part of typical activities of daily living controlled spasticity (stable administration of anti-spasticity medication) for the duration of the study Exclusion Criteria: lesion below 11th thoracic level (lower motoneuron injury) weight greater than 300 lbs or height greater than 6'1" femur length <35 cm or >47 cm and body weight >150 kg cardiac, musculoskeletal, or other uncontrolled health condition (e.g. orthostatic hypotension, osteoporosis) for which exercise or treadmill activity is contra-indicated existing skin irritation or open wounds/sores in lower extremity areas in contact with the leg cuffs of the Lokomat or body weight support harness existing cognitive impairment (as indicated by a Cognitive Capacity Screening Examination (CCSE) score of less than 24 out of 30) participation in rehabilitation therapy or other research study with exercise or mobility outcomes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania Lam, Ph.D
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janice J. Eng, Ph.D
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
Human Locomotion Lab, University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26230667
Citation
Lam T, Pauhl K, Ferguson A, Malik RN; BKin; Krassioukov A, Eng JJ. Training with robot-applied resistance in people with motor-incomplete spinal cord injury: Pilot study. J Rehabil Res Dev. 2015;52(1):113-29. doi: 10.1682/JRRD.2014.03.0090.
Results Reference
derived

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Enhancing Walking in People With Incomplete Spinal Cord Injury: a Pilot Study

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