Effects of Combined Treatment by Botulinum Toxin and Lokomat® on Walking Ability in Chronic Stroke

NCT03659266 | Completed

• 1 other identifier: 2017-69
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

75% patients in the chronic phase of a stroke keep walking disabilities. Focal spasticity in the paretic lower limb frequently causes these walking disabilities, and the gold standard treatment is intramuscular injection of Botulinum toxin A in the spastic muscles. To potentiate the effects of toxin, walking rehabilitation is usually prescribed in the weeks following injection, but the protocols vary and few have been evaluated in the medical literature. In particular, the effect on walking ability of combined treatment by botulinum toxin A and robot-assisted gait training has never been evaluated. Tested hypothesis: Robot-assisted gait training by Lokomat® motorized exoskeleton potentiates botulinum toxin's effects better than conventional walking therapy. The aim of this study was to evaluate the effects on walking ability of the association of focal spasticity treatment by Botulinum toxin and Lokomat-assisted walking rehabilitation in patients suffering from spastic hemiparesia after stroke in the chronic phase. Outcome:

• Primary: distance walked (meters) in the six-minute walk test (SMWT) Prospective, randomized, controlled, opened, monocentric study with a crossover design. Recruitment of patients over 18 years of age, in the chronic phase of stroke, who have already been treated by Botulinum toxin injection for focal spasticity in our PMR ward. Assessment at Day one (D0), Week four (W4) and Week eight (W8). Following a preliminary study which had the six-minute walk test as a secondary outcome, the expected results are a significant improvement of the distance walked in the SMWT after robotic rehabilitation, and a lack of significant improvement following conventional therapy. The study should serve to further harmonize and optimize rehabilitation protocols after toxin injections, and to justify the use of robotic rehabilitation for patients in the chronic phase of stroke.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Time of Ten-meter walk test

  Time is measure while the individual walks the set distance (10 meters). the distance covered is divided by the time it took the individual to walk that distance

  20 minutes

Study Arms (2)

Group 1

ACTIVE COMPARATOR

D0: Injection of Botulinum toxin A in triceps surae, according to pre-established modalities (no influence of the experimental protocol on this stage) W2-W4: Robotic walking rehabilitation by Lokomat® in the functional rehabilitation department (conventional hospitalization) W4-W6: Return to home, "wash-out"period W6-W8: Conventional walking rehabilitation in the functional rehabilitation department (conventional hospitalization)

Other: Robotic walking rehabilitation by Lokomat®; Other: Conventional walking rehabilitation

group 2

ACTIVE COMPARATOR

D0: Injection of Botulinum toxin A in triceps surae W2-W4: Conventional walking rehabilitation in the functional rehabilitation department (conventional hospitalization) W4-W6: Return to home, "wash-out"period W6-W8: Robotic walking rehabilitation by Lokomat® in the functional rehabilitation department (conventional hospitalization)

Other: Robotic walking rehabilitation by Lokomat®; Other: Conventional walking rehabilitation

Interventions

Robotic walking rehabilitation by Lokomat® OTHER

Lokomat sessions / week for 2 weeks. Each session lasts 45 minutes including 30 minutes of effective work of the march and 15 minutes of setting up.

Group 1; group 2

Conventional walking rehabilitation OTHER

5 physiotherapy sessions / week for 2 weeks. Each session lasts 45 minutes including 30 minutes of walking and 15 minutes of stretching

Group 1; group 2

Eligibility Criteria

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

You may qualify if:

• Age between 18 and 80 years
• Left or right spastic hemiparesia after a single unilateral hemorrhagic or ischemic stroke, in chronic phase (at least 6 months after stroke)
• Functional hindrance in walking
• Spasticity of paretic triceps surae allowing for focal treatment by Botulinum toxin injection

You may not qualify if:

• Inability to walk with or without technical aids \>5min
• Cognitive disorders disallowing informed consent
• Spasticity equal or superior to 4 on the triceps surae (On the Modified Ashworth Scale)
• Physical exercise not allowed: non stable cardiovascular or pulmonary disease in particular
• Lokomat® use not allowed: cutaneous lesions that could come in contact with the straps, non consolidated recent fracture (\<3months), severe disability in controlling trunk balance disallowing correct posture in Lokomat®, intra-abdominal cranial flap, weight\>135kg

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

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

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 6, 2018
• Study Start: March 7, 2019
• Primary Completion: July 2, 2021
• Study Completion: July 2, 2021
• Last Updated: June 14, 2024

Record last verified: 2022-12

Locations

FR (1)