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

Stroke Clinical Trial

— Lambda_MIpil  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05020171
• Other study ID #: 2021-00721
• Secondary ID: 14-O20
• Status: Terminated
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: January 29, 2024

Study information

• Verified date: May 2024
• Source: Institution de Lavigny
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 29, 2024
• Est. primary completion date: January 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Other:
• Group of physiotherapy not focus on strength training
2x a week during 5 weeks, active physical therapy treatment based on movement

Locations

Country	Name	City	State
Switzerland	Institution de Lavigny	Lavigny	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Institution de Lavigny

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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