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

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).

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Key information

Conditions

Gait, Hemiplegic Gait Disorders, Neurologic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Centro Neurolesi Bonino-Pulejo"

Messina, 98123, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age ≥ 55 years;
first, single, ischemic supra-tentorial stroke occurred at least 6 months before the study inclusion;
a Functional Ambulatory Categories (FAC) score of >2;
ability to control head and trunk posture;
no systemic or cardiovascular contraindication to LBPP

Exclusion criteria

Medical and/or psychiatric illness potentially interfering with the treatment.

Treatment and study plan

AlterG Treatment

Device

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.

Primary outcomes

Functional Ambulatory Categories

Time frame: 1 month

FAC is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device

Secondary outcomes

gait cycle duration

Time frame: 1 month

GCD is the time interval between two successive occurrences of one of the repetitive events of walking, herein the right heel strike),

Sponsors and collaborators

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: May 21, 2019
Registry last updated: May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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