NCT03957785

Lower Body Positive Pressure Treadmill Training in Post-Stroke Gait Impairment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: IRCCS Centro Neurolesi Bonino Pulejo · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

Lower body positive pressure (LBPP) decreases weight bearing and ground reaction forces, with potentially positive effects on qualitative gait indices. However, which gait features are shaped by LBPP gait training in post-stroke patients is still poorly predictable. A pilot study on the effects of LBPP gait training on qualitative and quantitative gait indices in patients with hemiparesis due to stroke in the chronic phase was carried out. Twenty-five patients who suffered from a first, single, ischemic, supra-tentorial stroke occurred at least 6 months before study inclusion were provided with 24 daily sessions of LBPP treadmill gait training using AlterG device. These patients were compared with 25 age-matched healthy controls (HC), who were formerly provided with the same amount of AlterG training, and 25 patients with the same clinical-demographic characteristics of the first group of patients, who previously underwent conventional treadmill gait training (TGT). Qualitative and quantitative gait features, including Functional Ambulation Categories, gait cycle features, and muscle activation patterns were analyzed before and after the training (AlterG or TGT).

Conditions

• Gait, Hemiplegic

Interventions

Type	Name	Description
DEVICE	AlterG Treatment	All participants practiced one session a day of AlterG or TGT (for 40min), six days a week, for four weeks (for a total amount of 24 sessions). All patients were trained using BWS, FAC-tailored physiotherapist assistance, and treadmill speed (S) to allow the participant to walk with the intermittent support of one physiotherapist to help with balance and coordination (FAC 2), with the visual supervision of one physiotherapist (FAC 3), or independently without using the handrails (FAC 4). BWS, physiotherapist assistance, and S were checked and adapted to subjects' progresses across the AlterG sessions. A qualitative (using FAC) and quantitative (spatio-temporal parameters and dynamic electromyography) gait assessment before and after the end of the monthly LBPP gait training was carried out.

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-01-31
• Completion: 2018-05-31
• First posted: 2019-05-21
• Last updated: 2019-05-22

Locations

1 site across 1 country: Italy