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

Effects of a Lower Limb Strength Training Program on a Seated Robotic Device in Subacute Acquired Brain Injury Patients: a Pilot Study.

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.

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Device: Group of strength training; Other: Group of physiotherapy not focus on strength training

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lavigny, Vaud, Switzerland, 1175
      • Institution de Lavigny

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; group focus on lower limb strength training with a seated robotic device	Device: 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
Active Comparator: control group; physiotherapy group as usual, not focused on strength training	Other: Group of physiotherapy not focus on strength training; 2x a week during 5 weeks, active physical therapy treatment based on movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from study inclusion to end of intervention at 5 weeks in strength of knee extensor's	measure with a manuel dynamometer, in newton	Study inclusion to end of intervention at 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from study inclusion to end of intervention at 5 weeks in Motricity index legs	clinical manuel strength test, seating on a chair. From 0 to 33, 33 is normal strength.	Study inclusion to end of intervention at 5 weeks
change from study inclusion to end of intervention at 5 weeks in timed up and go	Mobility test: standing from a chair, walking 3 meters, turn around, returning and seat. in seconds	Study inclusion to end of intervention at 5 weeks
change from study inclusion to end of intervention at 5 weeks in 10 meters walk test	measure of mean gait speed on 10 meters, at comfortable and maximum gait speed. In meters/second.	Study inclusion to end of intervention at 5 weeks
change from study inclusion to end of intervention at 5 weeks in Ashworth Scale (spasticity)	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.	Study inclusion to end of intervention at 5 weeks

Collaborators and Investigators

• Sponsor: Institution de Lavigny
• Investigators: Principal Investigator: Claude Pichonnaz, PhD, Haute Ecole de Santé Vaud

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): January 29, 2024
• Study Completion (Actual): January 29, 2024

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; lower limb; robotic device; strength training; subacute
• Other Study ID Numbers: 2021-00721; 14-O20 (Other Grant/Funding Number: Commission scientifique du domaine santé HES-SO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No