Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury

NCT01087918 | Completed Phase 1 Results

• 2 other identifiers: EK-21/2008CLI006/2 extension
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

ASIA C and D

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, after intervention (4 weeks)

• 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.

  Baseline, after intervention (4 weeks)

Secondary Outcomes (9)

• Walking Index for Spinal Cord Injury II

  Baseline, after intervention (4 weeks)

• Berg Balance Scale

  Baseline, after intervention (4 weeks)

• Spinal Cord Independence Measure III

  Baseline, after intervention (4 weeks)

• Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis

  Baseline, after intervention (4 weeks)

• Manual Muscle Test of the Lower Extremity

  Baseline, after intervention (4 weeks)

Study Arms (2)

First RAGT, then strength training

EXPERIMENTAL

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; Other: Strength Training

First strength training, then RAGT

EXPERIMENTAL

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; Other: Strength Training

Interventions

RAGT DEVICE

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

First RAGT, then strength training; First strength training, then RAGT

Strength Training OTHER

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

First RAGT, then strength training; First strength training, then RAGT

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 24401143 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Issues to find participants led to small numbers of subjects analyzed. Ambulatory activity besides our interventions was not controlled for.

Results Point of Contact

• Title: Hubertus van Hedel, PhD
• Organization: UZurich

hubertus.vanhedel@kispi.uzh.ch

+41 44 762 52 91

Study Officials

• Huub van Hedel, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: July 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 29, 2012
• Results First Posted: October 19, 2012

Record last verified: 2012-10

Locations

CH (1)