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

NCT ID: NCT05020171

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2024-01-29

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

intervention group

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

Group Type: EXPERIMENTAL

Group of strength training

Intervention Type: DEVICE

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

control group

physiotherapy group as usual, not focused on strength training

Group Type: ACTIVE_COMPARATOR

Group of physiotherapy not focus on strength training

Intervention Type: OTHER

2x a week during 5 weeks, active physical therapy treatment based on movement

Interventions

Group 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

Intervention Type: DEVICE

Group of physiotherapy not focus on strength training

2x a week during 5 weeks, active physical therapy treatment based on movement

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institution de Lavigny

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claude Pichonnaz, PhD

Role: PRINCIPAL_INVESTIGATOR

Haute Ecole de Santé Vaud

Locations

Institution de Lavigny

Lavigny, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

14-O20

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2021-00721

Identifier Type: -

Identifier Source: org_study_id