CompletedNot Applicable

Effect of Luna EMG Robotic Therapy on Physiotherapy Outcomes in Post-Ischemic Stroke Patients

Poland62 participantsStarted 2022-05-01

Plain-language summary

The study evaluates the effectiveness of the Luna EMG robotic system in the rehabilitation of patients after ischemic stroke. The main objective is to assess the impact of robotic-assisted training on gait speed, balance, and bioelectrical activity of the thigh muscles (rectus femoris and biceps femoris). The study also analyzes whether the side of hemiparesis (left vs. right) influences the outcomes of physiotherapy. Participants are randomly assigned to either an experimental group receiving robotic therapy combined with standard rehabilitation or a control group receiving standard rehabilitation alone.

Who can participate

Age range65 Years – 86 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of primary ischemic stroke * Time from stroke: 4 to 15 weeks * Age between 65 and 86 years * Limited or impaired lower limb function * Ability to walk 10 meters independently or with orthopedic assistance * Muscle strength of at least -3 on the modified Medical Research Council (MRC) scale * Cognitive function sufficient to understand instructions and participate in the study * Stable clinical status * Provided written informed consent Exclusion Criteria: * Hemorrhagic stroke or stroke in the posterior cerebral circulation * Lower limb spasticity greater than 1+ on the modified Ashworth Scale (MAS) * Functional limitations preventing the completion of selected tests * Recent orthopedic injuries affecting balance * Prior lower limb surgery * Sensory aphasia * Coexisting neurological disorders (e.g., Parkinson's disease, Huntington's disease) * Lack of patient cooperation or refusal to consent

What they're measuring

Change in Static and Dynamic Balance (Berg Balance Scale - BBS)

Timeframe: Baseline and at 4 weeks (post-intervention)

Change in Functional Mobility and Balance (Timed Up and Go Test - TUG)

Timeframe: Baseline and at 4 weeks (post-intervention)

Change in Trunk Control (Trunk Impairment Scale - TIS)

Timeframe: Baseline and at 4 weeks (post-intervention)

Change in Postural Control (Postural Assessment Scale for Stroke Patients - PASS)

Timeframe: Baseline and at 4 weeks (post-intervention)

Change in Gait Speed (10-Meter Walk Test - 10MWT)

Timeframe: Baseline and at 4 weeks (post-intervention)

Trial details

NCT IDNCT07280884

SponsorUniversity School of Physical Education, Krakow, Poland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-01

View on ClinicalTrials.gov More Ischemic Stroke trials

Plain-language summary

Who can participate

Age range65 Years – 86 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Static and Dynamic Balance (Berg Balance Scale - BBS)

Timeframe: Baseline and at 4 weeks (post-intervention)

Change in Functional Mobility and Balance (Timed Up and Go Test - TUG)

Timeframe: Baseline and at 4 weeks (post-intervention)

Change in Trunk Control (Trunk Impairment Scale - TIS)

Timeframe: Baseline and at 4 weeks (post-intervention)

Change in Postural Control (Postural Assessment Scale for Stroke Patients - PASS)

Timeframe: Baseline and at 4 weeks (post-intervention)

Change in Gait Speed (10-Meter Walk Test - 10MWT)

Timeframe: Baseline and at 4 weeks (post-intervention)