Post-stroke Gait Rehabilitation With a Unilateral Hip Exoskeleton: Clinical and Neuromuscular Outcomes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to evaluate the safety, reliability, and short-term effectiveness of SHAJA-based training in improving walking velocity and endurance in post-stroke patients. The main questions it aims to answer are: * Does the SHAJA-based training improve walking velocity and endurance in post-stroke patients compared to conventional gait training? * Is the SHAJA exoskeleton safe and reliable? Researchers will compare the SHAJA-based training to a conventional gait training to see if the former works to improve walking ability. Participants will: * Perform six SHAJA-assisted gait training sessions or six conventional gait training sessions * Perform five assessment sessions

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• cerebral stroke, at least 3 months from cerebral event

• ability to ambulate with no more than minimal contact assistance, even with aids (Functional Ambulation Classification, FAC \>= 43)

• self-selected walking velocity in the range \[0.3-0.85\] m/s

• anthropometry consistent with the specifications of the tested devices

• gait impairments that may benefit from hip assistance, e.g. hip weakness in flexion and/or extension (Medical Research Council, MRC, Scale for Muscle Strength \>2 and \<5 for flexion and extension)

Locations
Other Locations
Italy
Centro Riabilitativo Villa Beretta
NOT_YET_RECRUITING
Costa Masnaga
SD Neuroriabilitazione - Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Time Frame
Start Date: 2025-07-07
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: SHAJA first, then conventional
Patients will perform the SHAJA-assisted gait training during the first period of the trial followed by a conventional gait training during the second period of the trial
Experimental: Conventional first, then SHAJA
Patients will perform the conventional gait training during the first period of the trial followed by a SHAJA-assisted gait training during the second period of the trial
Related Therapeutic Areas
Sponsors
Leads: Carmelo Chisari
Collaborators: Scuola Superiore Sant'Anna di Pisa, Azienda Ospedaliero, Universitaria Pisana, Centro Riabilitativo Villa Beretta

This content was sourced from clinicaltrials.gov