Clinical trial NCT05020171: Effects of a Lower Limb Strength Training Program on a Seated Robotic Device in Patients
Official title: Effects of a Lower Limb Strength Training Program on a Seated Robotic Device in Subacute Acquired Brain Injury Patients: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: lower limb
robotic device
strength training
subacute
rehabilitation
Lead sponsor: Institution de Lavigny
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change from study inclusion to end of intervention at 5 weeks in strength of knee extensor's
timeFrame: Study inclusion to end of intervention at 5 weeks
Secondary outcomes:
measure: change from study inclusion to end of intervention at 5 weeks in Motricity index legs
timeFrame: Study inclusion to end of intervention at 5 weeks
measure: change from study inclusion to end of intervention at 5 weeks in timed up and go
timeFrame: Study inclusion to end of intervention at 5 weeks
measure: change from study inclusion to end of intervention at 5 weeks in 10 meters walk test
timeFrame: Study inclusion to end of intervention at 5 weeks
measure: change from study inclusion to end of intervention at 5 weeks in Ashworth Scale (spasticity)
timeFrame: Study inclusion to end of intervention at 5 weeks
Other outcomes:
Locations:
city: Lavigny
country: Switzerland
facility: Institution de Lavigny
state: Vaud
Study officials:
affiliation: Haute Ecole de Santé Vaud
name: Claude Pichonnaz, PhD
role: PRINCIPAL_INVESTIGATOR
References: