NCT00610974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

3.3 years

First QC Date

January 28, 2008

Last Update Submit

September 24, 2014

Conditions

Motor-incomplete Spinal Cord Injury

Keywords

Spinal cord injurywalkinggait trainingbody-weight supported treadmill trainingrehabilitation

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

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

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

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.

Behavioral: Body-weight supported treadmill training

2

EXPERIMENTAL

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.

Behavioral: Body-weight supported treadmill training

Interventions

Body-weight supported treadmill trainingBEHAVIORAL

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.

1

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • motor-incomplete SCI due to non-progressive lesion (e.g. trauma, ischemia) at least 12 months ago
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Locomotion Lab, University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Related Publications (1)

  • 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.

    PMID: 26230667DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Tania Lam, Ph.D

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Janice J. Eng, Ph.D

    University of British Columbia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 8, 2008

Study Start

March 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

CA(1)