Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087918
• Other study ID #: EK-21/2008
• Secondary ID: CLI006/2 extensi
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 15, 2010
• Last updated: October 22, 2012
• Start date: July 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2012
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	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.	Baseline, after intervention (4 weeks)	No
Secondary	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.	Baseline, after intervention (4 weeks)	No
Secondary	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.	Baseline, after intervention (4 weeks)	No
Secondary	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.	Baseline, after intervention (4 weeks)	No
Secondary	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.	Baseline, after intervention (4 weeks)	No
Secondary	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.	Baseline, after intervention (4 weeks)	No
Secondary	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.	Baseline, after intervention (4 weeks)	No
Secondary	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.	Baseline, after intervention (4 weeks)	No
Secondary	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.	Baseline, after intervention (4 weeks)	No

External Links

•   Description of study