An interventional study of Group of strength training and Group of physiotherapy not focus on strength training in Stroke, sponsored by Institution de Lavigny. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by Institution de Lavigny · Not applicable, Interventional, and Treatment
The loss of lower limb strength that occurs after an Acquired Brain Injury (ABI) limits the patient's autonomy in participating in activities of daily living, including gait performance. In the sub-acute phase, it is difficult to implement a strengthening program, as weakness prevents exercise being performed with the recommended parameters. This limit can be exceeded by using specific robotic devices, which allow the effort provided to be adapted according to the patient's capacities. In addition, motivation can be improved by the use of feedback or incentive games. The aim of this pilot study is to obtain data on the effect of lower limb strength training with a seated robotic device in subacute ABI patients for a future larger randomised study. In addition, it aims to evaluate the recruitment rate, applicability, resources for implementation and patient tolerance to the training program.
7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 5 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Institution de Lavigny is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
group focus on lower limb strength training with a seated robotic device
Device: Group of strength training
physiotherapy group as usual, not focused on strength training
Other: Group of physiotherapy not focus on strength training
2x a week during 5 weeks, strengthening of weak muscles with the intensity recommended in the literature, i.e. 3-4x15 repetition at an intensity of 50 to 80% of the maximum force combined with serious games to stimulate patient involvement in strength training
2x a week during 5 weeks, active physical therapy treatment based on movement
change from study inclusion to end of intervention at 5 weeks in strength of knee extensor's
measure with a manuel dynamometer, in newton
Time frame: Study inclusion to end of intervention at 5 weeks
change from study inclusion to end of intervention at 5 weeks in Motricity index legs
clinical manuel strength test, seating on a chair. From 0 to 33, 33 is normal strength.
Time frame: Study inclusion to end of intervention at 5 weeks
change from study inclusion to end of intervention at 5 weeks in timed up and go
Mobility test: standing from a chair, walking 3 meters, turn around, returning and seat. in seconds
Time frame: Study inclusion to end of intervention at 5 weeks
change from study inclusion to end of intervention at 5 weeks in 10 meters walk test
measure of mean gait speed on 10 meters, at comfortable and maximum gait speed. In meters/second.
Time frame: Study inclusion to end of intervention at 5 weeks
change from study inclusion to end of intervention at 5 weeks in Ashworth Scale (spasticity)
measure of the resistance of a muscle to passive stretch according to REsistance to PASsive movement protocol. From 0 to 4, 4 is high spasticity.
Time frame: Study inclusion to end of intervention at 5 weeks
Plan to share: No
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Ran from Sep 2021 to primary completion in Jan 2024, 28 months.
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This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Institution de Lavigny