Stroke
Conditions
Keywords
lower limb, robotic device, strength training, subacute, rehabilitation
Brief summary
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.
Interventions
DEVICEGroup of 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
OTHERGroup of physiotherapy not focus on strength training
2x a week during 5 weeks, active physical therapy treatment based on movement
Sponsors
Institution de Lavigny
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acquired Brain Injury of vascular, traumatic, infectious or tumoral origin in the subacute phase * Walking ability ≤ Functional Ambulatory Category level 5 (1-6) * Paresis of the lower limb: strength \<57/100 on the Motricity Index * Cognitive and memory functions allowing the patient to follow treatment instructions and give informed consent
Exclusion criteria
* Significant heart problem * Venous thrombosis less than 6 months * Musculoskeletal impairment not compatible with movement * Degenerative neurological disease * Oxygen-dependent * Blood pressure not stabilized
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from study inclusion to end of intervention at 5 weeks in strength of knee extensor's | Study inclusion to end of intervention at 5 weeks | measure with a manuel dynamometer, in newton |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change from study inclusion to end of intervention at 5 weeks in Motricity index legs | Study inclusion to end of intervention at 5 weeks | clinical manuel strength test, seating on a chair. From 0 to 33, 33 is normal strength. |
| change from study inclusion to end of intervention at 5 weeks in timed up and go | Study inclusion to end of intervention at 5 weeks | Mobility test: standing from a chair, walking 3 meters, turn around, returning and seat. in seconds |
| change from study inclusion to end of intervention at 5 weeks in 10 meters walk test | Study inclusion to end of intervention at 5 weeks | measure of mean gait speed on 10 meters, at comfortable and maximum gait speed. In meters/second. |
| change from study inclusion to end of intervention at 5 weeks in Ashworth Scale (spasticity) | Study inclusion to end of intervention at 5 weeks | 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. |
Countries
Switzerland
Outcome results
None listed