NCT03659266: Lokomat

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

Completed NA Last updated 14 June 2024

What this trial tests

NA trial testing Robotic walking rehabilitation by Lokomat® in Stroke in 34 participants. Completed in 2 July 2021.

Timeline

7 March 2019

Primary endpoint
2 July 2021

2 July 2021

Quick facts

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	34
Start date	7 March 2019
Primary completion	2 July 2021
Estimated completion	2 July 2021
Sites	1 location across France

Drugs / interventions tested

• Robotic walking rehabilitation by Lokomat®
• Conventional walking rehabilitation

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Electromechanical-assisted training for walking after stroke.
   Mehrholz J, Thomas S, Kugler J, Pohl M, et al · · 2020 · cited 146× · PMID 33091160 · DOI 10.1002/14651858.cd006185.pub5