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

NCT05020171 | Terminated DMC

• 2 other identifiers: 2021-0072114-O20
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

lower limb; robotic device; strength training; subacute; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• change from study inclusion to end of intervention at 5 weeks in Motricity index legs

  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

  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

  Study inclusion to end of intervention at 5 weeks

• change from study inclusion to end of intervention at 5 weeks in Ashworth Scale (spasticity)

  Study inclusion to end of intervention at 5 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

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

Device: Group of strength training

control group

ACTIVE COMPARATOR

physiotherapy group as usual, not focused on strength training

Other: Group of physiotherapy not focus on strength training

Interventions

Group of strength training 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

intervention group

Group of physiotherapy not focus on strength training OTHER

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

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant heart problem
• Venous thrombosis less than 6 months
• Musculoskeletal impairment not compatible with movement
• Degenerative neurological disease
• Oxygen-dependent
• Blood pressure not stabilized

Sponsors & Collaborators

• Institution de Lavigny: lead

Study Sites (1)

Institution de Lavigny

Lavigny, Canton of Vaud, 1175, Switzerland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Claude Pichonnaz, PhD

  Haute Ecole de Santé Vaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 25, 2021
• Study Start: September 20, 2021
• Primary Completion: January 29, 2024
• Study Completion: January 29, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)