Effects of a Lower Limb Strength Training Program on a Seated Robotic Device in Patients (Lambda_MIpil)

Institution de Lavigny

Status: Terminated

Conditions: Stroke

Treatments: Device: Group of strength training; Other: Group of physiotherapy not focus on strength training

Study type: Interventional

Funder types: Other

Identifiers

NCT05020171

14-O20 (Other Grant/Funding Number)

2021-00721

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups

intervention group

Experimental group

Description:

group focus on lower limb strength training with a seated robotic device

Treatment:

Device: Group of strength training

control group

Active Comparator group

Description:

physiotherapy group as usual, not focused on strength training

Treatment:

Other: Group of physiotherapy not focus on strength training