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Completed

NCT Number: NCT01087918

Lokomat Versus Strength Training in 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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RAGT

Device

16 sessions / 4 times/week / 45 minutes Lokomat training

Strength training

Other

16 sessions / 4 times/week / 45 minutes lower extremity strength training

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 16, 2010
Registry last updated
Oct 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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