NCT03957785

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

Completed NA Last updated 22 May 2019

What this trial tests

NA trial testing AlterG Treatment in Gait, Hemiplegic in 75 participants. Completed in 31 May 2018.

Timeline

1 June 2017

Primary endpoint
31 January 2018

31 May 2018

Quick facts

Lead sponsor	IRCCS Centro Neurolesi Bonino Pulejo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	75
Start date	1 June 2017
Primary completion	31 January 2018
Estimated completion	31 May 2018
Sites	1 location across Italy

Drugs / interventions tested

• AlterG Treatment

Conditions studied

• Gait, Hemiplegic — all drugs for Gait, Hemiplegic →

Sponsor

IRCCS Centro Neurolesi Bonino Pulejo — full company profile →

Who can join

55 and older, any sex, with Gait, Hemiplegic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.