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

NCT03957785 | Completed

• 1 other identifier: IRCCSME 19/2017
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Functional Ambulatory Categories

  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

  1 month

Secondary Outcomes (1)

• gait cycle duration

  1 month

Study Arms (3)

Alter G treatment

EXPERIMENTAL

All participants practiced one session a day of AlterG (for 40min), six days a week, for four weeks (for a total amount of 24 sessions). All patients were trained using BWS, and treadmill speed (S) to allow the participant to walk with the intermittent support of one physiotherapist to help with balance and coordination. A qualitative (using FAC) and quantitative (spatio-temporal parameters and dynamic electromyography) gait assessment before and after the end of the gait training was performed.

Device: AlterG Treatment

Traditional Gait Training

ACTIVE COMPARATOR

All participants practiced one session a day TGT (for 40min), six days a week, for four weeks (for a total amount of 24 sessions). All patients were trained using FAC-tailored physiotherapist assistance, 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). Physiotherapist assistance, and S were checked and adapted to subjects' progresses across the AlterG sessions.

Device: AlterG Treatment

Healthy Control

ACTIVE COMPARATOR

ll participants practiced one session a day of AlterG (for 40min), six days a week, for four weeks (for a total amount of 24 sessions). All patients were trained using BWS, and treadmill speed (S) to allow the participant to walk with the intermittent support of one physiotherapist to help with balance and coordination. A qualitative (using FAC) and quantitative (spatio-temporal parameters and dynamic electromyography) gait assessment before and after the end of the gait training was performed.The HC initially practiced the device at the same BWS and S administered to the patients. BWS and S were reduced progressively and increased, respectively, across the AlterG sessions in keeping with patients progresses.

Device: AlterG Treatment

Interventions

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.

Alter G treatment; Healthy Control; Traditional Gait Training

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 55 years;
• a Functional Ambulatory Categories (FAC) score of \>2;
• ability to control head and trunk posture;
• no systemic or cardiovascular contraindication to LBPP

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi Bonino-Pulejo"

Messina, 98123, Italy

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: June 1, 2017
• Primary Completion: January 31, 2018
• Study Completion: May 31, 2018
• Last Updated: May 22, 2019

Record last verified: 2019-05

Locations

IT (1)