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Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
RAGT
Strength Training
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Cord Injury focused on measuring ASIA C and D

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Time since lesion > 1 year
  • Outdoor mobility SCIM III < 5
  • Stable walking capacity

Exclusion Criteria:

  • participating on other training studies
  • osteoporosis
  • psychiatric diseases
  • epilepsia
  • body weight > 130 kg
  • cardiac pacemaker

Sites / Locations

  • Balgrist University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

First RAGT, then strength training

First strength training, then RAGT

Arm Description

16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.

16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.

Outcomes

Primary Outcome Measures

10 Meter Walking at Preferred Speed
The 10 meter walk test assesses the time required to walk 10 meters at the patient's preferred speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
10 Meter Walking at Maximal Speed
The 10 meter walking speed assesses the time needed to walk 10 meters at maximal speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.

Secondary Outcome Measures

Walking Index for Spinal Cord Injury II
The WISCI II describes whether a patients requires waling aids, braces or personal assistance to walk 10 meters. It is an ordinal scale varying from 0 (= not able to walk 10 meters) to 20 (= able to walk 10 meters with no walking aids, braces or personal assistance). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Berg Balance Scale
The Berg Balance Scale is a performance-based measure of balance. It is scored from 0 (= failed all items) to 56 points (= scored maximally in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Spinal Cord Independence Measure III
The SCIM assesses functional independence after spinal cord injury. It is scored from 0 (= total dependence in everyday life) to 100 points (= complete independence in everyday life). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis
Motor evoked potential was elicited by transcranial magnetic stimulation. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Manual Muscle Test of the Lower Extremity
With the manual muscle test, we examined strength of the lower extremities. Five key muscles on each side are evaluated from 0 (= total paralysis) to 5 (= normal strength). Values for left and right were then averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Pain on a Visual Analogue Scale
Pain was scored on a visual analogue scale from 0 (= no pain) to 100 (= maximal pain). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Response Time of the Lower Extremities
We measured choice stepping response time on a plate in a standing position. Participant had to move their feet to flashing LEDs as fast as possible. Valid values of the right and the left foot were averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Falls Efficacy Scale
The Falls Efficacy Scale evaluates fear of falling in everyday life situations. It is scored from 16 (= no fear at all) to 64 points (= maximal fear in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Figure of Eight Test
The Figure of Eight Test is a 10m Walk Test in the shape of a figure of eight. Time for completion of one lap is recorded and converted to [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.

Full Information

First Posted
March 15, 2010
Last Updated
October 22, 2012
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01087918
Brief Title
Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury
Official Title
Effects of Automated Treadmill Training and Lower Extremity Strength Training on Walking-related and Other Outcomes in Subjects With Chronic Incomplete Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this pilot study is to investigate whether gait specific robotic supported bodyweight supported treadmill training and lower extremity strength training have similar beneficial effects on walking function and other outcomes.
Detailed Description
Although task-specific training has been promoted during the last years to improve function, recent studies showed that after an incomplete spinal cord injury, strength, but not complex movement coordination, is affected. In this randomized cross-over trial we investigate the effectiveness of a task-specific 4 week Lokomat training with a 4 week (unspecific) lower extremity muscle strength training on walking-related and other outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
ASIA C and D

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First RAGT, then strength training
Arm Type
Experimental
Arm Description
16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
Arm Title
First strength training, then RAGT
Arm Type
Experimental
Arm Description
16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
Intervention Type
Device
Intervention Name(s)
RAGT
Intervention Description
16 sessions / 4 times/week / 45 minutes Lokomat training
Intervention Type
Other
Intervention Name(s)
Strength Training
Intervention Description
16 sessions / 4 times/week / 45 minutes lower extremity strength training
Primary Outcome Measure Information:
Title
10 Meter Walking at Preferred Speed
Description
The 10 meter walk test assesses the time required to walk 10 meters at the patient's preferred speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Time Frame
Baseline, after intervention (4 weeks)
Title
10 Meter Walking at Maximal Speed
Description
The 10 meter walking speed assesses the time needed to walk 10 meters at maximal speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Time Frame
Baseline, after intervention (4 weeks)
Secondary Outcome Measure Information:
Title
Walking Index for Spinal Cord Injury II
Description
The WISCI II describes whether a patients requires waling aids, braces or personal assistance to walk 10 meters. It is an ordinal scale varying from 0 (= not able to walk 10 meters) to 20 (= able to walk 10 meters with no walking aids, braces or personal assistance). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Time Frame
Baseline, after intervention (4 weeks)
Title
Berg Balance Scale
Description
The Berg Balance Scale is a performance-based measure of balance. It is scored from 0 (= failed all items) to 56 points (= scored maximally in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Time Frame
Baseline, after intervention (4 weeks)
Title
Spinal Cord Independence Measure III
Description
The SCIM assesses functional independence after spinal cord injury. It is scored from 0 (= total dependence in everyday life) to 100 points (= complete independence in everyday life). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Time Frame
Baseline, after intervention (4 weeks)
Title
Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis
Description
Motor evoked potential was elicited by transcranial magnetic stimulation. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Time Frame
Baseline, after intervention (4 weeks)
Title
Manual Muscle Test of the Lower Extremity
Description
With the manual muscle test, we examined strength of the lower extremities. Five key muscles on each side are evaluated from 0 (= total paralysis) to 5 (= normal strength). Values for left and right were then averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Time Frame
Baseline, after intervention (4 weeks)
Title
Pain on a Visual Analogue Scale
Description
Pain was scored on a visual analogue scale from 0 (= no pain) to 100 (= maximal pain). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Time Frame
Baseline, after intervention (4 weeks)
Title
Response Time of the Lower Extremities
Description
We measured choice stepping response time on a plate in a standing position. Participant had to move their feet to flashing LEDs as fast as possible. Valid values of the right and the left foot were averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Time Frame
Baseline, after intervention (4 weeks)
Title
Falls Efficacy Scale
Description
The Falls Efficacy Scale evaluates fear of falling in everyday life situations. It is scored from 16 (= no fear at all) to 64 points (= maximal fear in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Time Frame
Baseline, after intervention (4 weeks)
Title
Figure of Eight Test
Description
The Figure of Eight Test is a 10m Walk Test in the shape of a figure of eight. Time for completion of one lap is recorded and converted to [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Time Frame
Baseline, after intervention (4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Time since lesion > 1 year Outdoor mobility SCIM III < 5 Stable walking capacity Exclusion Criteria: participating on other training studies osteoporosis psychiatric diseases epilepsia body weight > 130 kg cardiac pacemaker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huub van Hedel, PhD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Balgrist University Hospital
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24401143
Citation
Labruyere R, van Hedel HJ. Strength training versus robot-assisted gait training after incomplete spinal cord injury: a randomized pilot study in patients depending on walking assistance. J Neuroeng Rehabil. 2014 Jan 9;11:4. doi: 10.1186/1743-0003-11-4.
Results Reference
derived

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Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury

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