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

Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo" (Other)
Overall Status
Completed
CT.gov ID
NCT03957785
Collaborator
(none)
75
1
3
12
6.3

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Device: AlterG Treatment
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Lower Body Positive Pressure Treadmill Training in Post-Stroke Gait Impairment
Actual Study Start Date :
Jun 1, 2017
Actual Primary Completion Date :
Jan 31, 2018
Actual Study Completion Date :
May 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Alter G treatment

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
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.

Active Comparator: Traditional Gait Training

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
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.

Active Comparator: Healthy Control

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
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.

Outcome Measures

Primary Outcome Measures

  1. Functional Ambulatory Categories [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 Outcome Measures

  1. gait cycle duration [1 month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Centro Neurolesi Bonino-Pulejo" Messina Italy 98123

Sponsors and Collaborators

  • IRCCS Centro Neurolesi "Bonino-Pulejo"

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rocco Salvatore Calabrò, Clinical Professor, IRCCS Centro Neurolesi "Bonino-Pulejo"
ClinicalTrials.gov Identifier:
NCT03957785
Other Study ID Numbers:
  • IRCCSME 19/2017
First Posted:
May 21, 2019
Last Update Posted:
May 22, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2019