Effectiveness of Multiple Robotic Gait-Devices for Improving Walking Ability in Subacute Stroke Patients

Neuron, Spain

Status: Withdrawn

Conditions: Stroke; Gait Disorders, Neurologic; Walking

Treatments: Device: Lexo; Device: C-Mill; Device: Lokomat; Device: Body-weight support treadmill

Study type: Interventional

Funder types: Other

Identifiers

NCT05811494

ALC001NR003

Details and patient eligibility

About

The purpose of this study is to know the effectiveness of different robotic devices for gait rehabilitation in stroke patients

Full description

Subjects will attend the Neuron rehabilitation clinic on their own to begin a rehabilitation program. After being recruited for the study and signing informed consent the patient will be assessed with the Timed Up and Go Test and 10 Meter Walking Test, and it will be realized a spatio temporal variables analysis with baiobit system and a superficial Electomiografic activity analysis during gait with Noraxon system.

Once the assessment is completed, the participant will receive the treatment assigned at his rehabilitation clinic. The patient will receive 30 minutes of robotic treatment with Lexi, Lokomat, C-Mill or the body-weight support treadmill and 15 minutes of overground walking training between 70-85% of HR max.

Once the treatment period is over, after 25 sessions, the assessment will be carried out again, recording the initial tests in the same order by the same assessors.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having suffered an ischaemic or haemorrhagic stroke with less than 6 months of evolution at the start of the study
• Presenting gait deficits compatible with a level between 2 and 3 of the functional category of gait (FAC)
• More than 20 seconds in the Time Up and Go test
• Less than 3 points on the Reisberg Global Deterioration Scale (GDS-R).

Exclusion criteria

• Presenting any type of specific contraindication to use the robotic device to be used with respect to their group. Thus, those patients who present a limitation in the range of movement in the hip of more than 0º of extension and 40º of flexion, in the knee of less than 30º of flexion and in the ankle of less than 0º of dorsal flexion will not be able to participate in the study.
• Lower limb spasticity greater than 3 on the modified Asworth scale
• Unable to maintain an assisted standing position for more than 5 minutes
• Unable to understand simple commands

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 4 patient groups

End-Effector walking training

Experimental group

Description:

Participants in the End-effector group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of Lexo training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers.

Treatment:

Device: Lexo

Fixed Exoskeleton walking training

Experimental group

Description:

Participants in the fixed-exoskeleton group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of Lokomat training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers.

Treatment:

Device: Lokomat

Body-Weight Support treadmill training with augmented reality

Experimental group

Description:

Participants in the Body-Weight Support treadmill training with augmented reality group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of C-Mill training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers.

Treatment:

Device: C-Mill

Body-Weight Support treadmill training

Active Comparator group

Description:

Participants in the Body-Weight Support treadmill training group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of body-weight support treadmill training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers.

Treatment:

Device: Body-weight support treadmill