Effect of Robotised Gait Training on Dynamic Balance, Symmetry and Push-off in Persons After Stroke

NCT03782948 | Completed

• 1 other identifier: URIS201802
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Rehabilitation robotics is increasingly used because it enables the patients to practice a wide array of movements. Dynamic balance training is essential for gait rehabilitation and robotised devices enhance repeatability, objectivity and precision of such training combined with monitoring and recording of kinematic and kinetic data. The aim of the study is to explore the effect of robot-assisted gait training on dynamic balance, symmetry and take-off in patients after stroke. The investigators will conduct a randomised intervention study where one group will receive visual feedback on gait status and the other group will receive kinetically-assisted training using a robotised device in addition to the visual feedback.

Conditions

Stroke

Keywords

gait training; dynamic balance; gait symmetry; rehabilitation robotics

Outcome Measures

Primary Outcomes (1)

• Change in postural stability during walking

  Assessed using the Functional Gait Assessment (FGA) scale. The scale scores range from 0 to 30, with higher scores indicating less impairment.

  Assessment before and after the 3-week training programme

Secondary Outcomes (6)

• Change in functional ambulation category

  Assessment before and after the 3-week training programme

• Change in functional independence

  Assessment before and after the 3-week training programme

• Change in fall-risk related mobility

  Assessment before and after the 3-week training programme

• Change in ability to change directions while stepping

  Assessment before and after the 3-week training programme

• Change in walking speed over a short distance

  Assessment before and after the 3-week training programme

Other Outcomes (1)

• Changes in kinesiological characteristics of gait

  Assessment before and after the 3-week training programme

Study Arms (2)

Controls

ACTIVE COMPARATOR

In each session, the group will undergo standard gait training on BART without pelvic perturbations, i.e., * walk a virtual track on the BART without pelvic perturbations (i.e., the pelvic brace of the BART device will be set to follow the patient's motion) for 10 minutes; * practise gait symmetry and take-off using visual feedback without pelvic perturbations in two 10-minute sessions.

Device: Standard gait training on BART without pelvic perturbations

Experimental

EXPERIMENTAL

In each session, the group will undergo robotised gait training with BART with pelvic perturbations, i.e., * walk a virtual track on the BART with pelvic perturbations during virtual uphill walk and virtual curved walk for 10 minutes; * practise gait symmetry and take-off using visual feedback with pelvic perturbations for 10 minutes; * practise dynamic gait balance using pelvic perturbations during treadmill walking for 10 minutes.

Device: Robotised gait training with BART with pelvic perturbations

Interventions

Standard gait training on BART without pelvic perturbations DEVICE

The Balance Assisted Robot on Treadmill (BART) enables various types of gait training on treadmill with visual feedback. It interfaces to the pelvis of the walking subject in an actuated and admittance-controlled manner, thus providing transparent haptic interaction with negligible power transfer.

Controls

Robotised gait training with BART with pelvic perturbations DEVICE

In addition to the standard gait training, the BART will deliver perturbations in the forward/backward and left/right direction.

Experimental

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subacute phase after first ischaemic or haemorrhagic stroke (less than 6 months after stroke);
• Limb hemiparesis;
• Ability to walk independently (FAC 6) or with assistance (FAC 5) on flat and uneven surfaces, stairs and slopes;
• Adequate cardiovascular ability (NYHA 1).

You may not qualify if:

• Degenerative process or postoperative condition on lower-limb joints that would hinder gait;
• Associated neurological disease;
• Decreased cognitive ability (KPSS \< 25).

Sponsors & Collaborators

• University Rehabilitation Institute, Republic of Slovenia: lead

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Matjaž Zadravec, PhD

  University Rehabilitation Institute, Republic of Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: January 31, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 15, 2021

Record last verified: 2021-02

Locations

SL (1)