Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury

October 22, 2012 updated by: University of Zurich

Effects of Automated Treadmill Training and Lower Extremity Strength Training on Walking-related and Other Outcomes in Subjects With Chronic Incomplete Spinal Cord Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8008
        • Balgrist University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: First RAGT, then strength training
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.
Device: RAGT
16 sessions / 4 times/week / 45 minutes Lokomat training
Other: Strength Training
16 sessions / 4 times/week / 45 minutes lower extremity strength training
Experimental: First strength training, then RAGT
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.
Device: RAGT
16 sessions / 4 times/week / 45 minutes Lokomat training
Other: Strength Training
16 sessions / 4 times/week / 45 minutes lower extremity strength training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10 Meter Walking at Preferred Speed
Time Frame: Baseline, after intervention (4 weeks)
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.
Baseline, after intervention (4 weeks)
10 Meter Walking at Maximal Speed
Time Frame: Baseline, after intervention (4 weeks)
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.
Baseline, after intervention (4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking Index for Spinal Cord Injury II
Time Frame: Baseline, after intervention (4 weeks)
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.
Baseline, after intervention (4 weeks)
Berg Balance Scale
Time Frame: Baseline, after intervention (4 weeks)
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.
Baseline, after intervention (4 weeks)
Spinal Cord Independence Measure III
Time Frame: Baseline, after intervention (4 weeks)
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.
Baseline, after intervention (4 weeks)
Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis
Time Frame: Baseline, after intervention (4 weeks)
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.
Baseline, after intervention (4 weeks)
Manual Muscle Test of the Lower Extremity
Time Frame: Baseline, after intervention (4 weeks)
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.
Baseline, after intervention (4 weeks)
Pain on a Visual Analogue Scale
Time Frame: Baseline, after intervention (4 weeks)
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.
Baseline, after intervention (4 weeks)
Response Time of the Lower Extremities
Time Frame: Baseline, after intervention (4 weeks)
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.
Baseline, after intervention (4 weeks)
Falls Efficacy Scale
Time Frame: Baseline, after intervention (4 weeks)
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.
Baseline, after intervention (4 weeks)
Figure of Eight Test
Time Frame: Baseline, after intervention (4 weeks)
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.
Baseline, after intervention (4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Huub van Hedel, PhD, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

March 15, 2010

First Submitted That Met QC Criteria

March 15, 2010

First Posted (Estimate)

March 16, 2010

Study Record Updates

Last Update Posted (Estimate)

October 29, 2012

Last Update Submitted That Met QC Criteria

October 22, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-21/2008
  • CLI006/2 extension (Other Grant/Funding Number: Spinal Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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