NCT03348215: ENTRES

Enhanced Treadmill Gait Training With Lower Limb Support After Stroke

Completed NA Last updated 15 February 2024

What this trial tests

NA trial testing Enhanced Treadmill Training in Stroke in 21 participants. Completed in 31 October 2019.

Timeline

1 June 2018

Primary endpoint
1 September 2019

31 October 2019

Quick facts

Lead sponsor	University of Strathclyde
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	1 June 2018
Primary completion	1 September 2019
Estimated completion	31 October 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• Enhanced Treadmill Training

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

University of Strathclyde

Who can join

18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This series of single case studies aims to test the feasibility and acceptability of an enhanced treadmill system for the recovery of gait function in stroke survivors. Forty adult participants who have had a stroke in the past year that resulted in impaired gait function and are attending a local hospital for gait training, will be recruited. Participants will be asked to attend a rehabilitation clinic for seven weeks, three times a week where they will receive enhanced treadmill training supervised by a physiotherapist. Assessment sessions will take place in week 1, weeks 5 and 8, and after 3 months. Outcome measures recorded during assessment sessions will include gait variables (e.g. speed, cadence, step length and joint kinematics) measured overground and on the treadmill using motion capture technology and outside using body worn sensors (inertial motion unit). Participants will complete a questionnaire on their community walking habits and asked to wear a physical activity monitor for 48 hours to record stepping time.

The basic intervention will comprise of walking on a treadmill capable of adjusting its speed to match that of the user (using feedback from the motion capture system) and a large television screen showing a virtual reality scene (woodland walking) with visual perturbations (virtual obstacle avoidance). In addition participants will be divided equally and randomly (Latin square) to either wear an ankle foot orthosis (AFO group) or functional electrical stimulation (FES group) while walking on the treadmill but not provided for home use. Training sessions will last up to a max of 20 minutes, will be supervised by a physiotherapist and participants will wear a safety harness to remove any risk of trip falls. Any adverse event such as muscle/joint pain, illness or a fall at home will be recorded, participants and physiotherapists will also be asked for feedback on their experience with the treadmill system using questionnaires and semi-structured interviews

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Treadmill training augmented with real-time visualisation feedback and function electrical stimulation for gait rehabilitation after stroke: a feasibility study.
   Phongamwong C, Rowe P, Chase K, Kerr A, et al · · 2019 · cited 9× · PMID 32903355 · DOI 10.1186/s42490-019-0020-1