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

Not Applicable

Terminated

• Conditions: Stroke
• Interventions: Device: Group of strength training; Other: Group of physiotherapy not focus on strength training

• Registration Number: NCT05020171
• Lead Sponsor: Institution de Lavigny

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-25
• Study Start: 2021-09-20
• Primary Completion: 2024-01-29
• Study Completion: 2024-01-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Group of strength training	group focus on lower limb strength training with a seated robotic device
control group	Group of physiotherapy not focus on strength training	physiotherapy group as usual, not focused on strength training

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Institution de Lavigny; 🇨🇭 Lavigny, Vaud, Switzerland