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

Primary Purpose

Gait, Hemiplegic

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
AlterG Treatment
Sponsored by
IRCCS Centro Neurolesi "Bonino-Pulejo"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gait, Hemiplegic

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • IRCCS Centro Neurolesi Bonino-Pulejo"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Alter G treatment

Traditional Gait Training

Healthy Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 17, 2019
Last Updated
May 21, 2019
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
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1. Study Identification

Unique Protocol Identification Number
NCT03957785
Brief Title
Lower Body Positive Pressure Treadmill Training in Post-Stroke Gait Impairment
Official Title
Lower Body Positive Pressure Treadmill Training in Post-Stroke Gait Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Hemiplegic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alter G treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Gait Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Healthy Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
AlterG Treatment
Intervention Description
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 Outcome Measure Information:
Title
Functional Ambulatory Categories
Description
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
Time Frame
1 month
Secondary Outcome Measure Information:
Title
gait cycle duration
Description
GCD is the time interval between two successive occurrences of one of the repetitive events of walking, herein the right heel strike),
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
IRCCS Centro Neurolesi Bonino-Pulejo"
City
Messina
ZIP/Postal Code
98123
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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