Unilateral hip exoskeleton
DeviceUnilateral hip exoskeleton assisted gait training. Gait training will consist of overground walking with the exoskeleton SHAJA for 30-40 minutes.
NCT Number: NCT07035730
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
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Centro Riabilitativo Villa Beretta, Costa Masnaga, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Unilateral hip exoskeleton assisted gait training. Gait training will consist of overground walking with the exoskeleton SHAJA for 30-40 minutes.
Conventional gait training will consist of overground walking without the exoskeleton SHAJA for 30-40 minutes.
Time frame: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1
Time frame: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1
Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
The Berg Balance Scale ranges from 0 to 56, with higher scores indicating better performance
Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
The Motricity Index ranges from 0 to 100, with higher scores indicating better performance
Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
The Modified Ashworth Scale ranges from 0 to 4, with lower scores indicating better outcome
Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
The Functional Ambulation Classification ranges from 1 to 6, with higher scores indicating better performance
Time frame: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1
Time frame: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1
Time frame: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1
Time frame: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1
Carmelo Chisari
Other
Post-stroke Gait Rehabilitation With a Unilateral Hip Exoskeleton: Clinical and Neuromuscular Outcomes
Acronym: SHAJA-R
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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