Enhanced Treadmill Gait Training With Lower Limb Support After Stroke

NCT03348215 | Completed

• 1 other identifier: SU_BME_KERR01102017
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Keywords

Gait rehabilitation

Outcome Measures

Primary Outcomes (1)

• Participant compliance with the intervention

  Proportion of participants attending 60% of training sessions.

  12 months

Secondary Outcomes (5)

• Community walking ability

  12 months

• Physical activity behaviour

  12 months

• Gait performance

  12 months

• Participant satisfaction with the enhanced treadmill training.

  12 months

• Participants satisfaction with the intervention and overall research experience

  12 months

Study Arms (1)

Enhanced Treadmill Training

OTHER

Treadmill walking with an immersive environment and bio mechanical support (body weight, ankle-foot -orthosis and functional electrical stimulation)

Other: Enhanced Treadmill Training

Interventions

Enhanced Treadmill Training OTHER

6 week programme of treadmill training with addition of an immersive environment (virtual reality projection), body weight support, orthotics and functional electrical stimulation

Enhanced Treadmill Training

Eligibility Criteria

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

You may qualify if:

• Over 18 years old.
• Have had a diagnosed stroke.
• Onset of stroke between 1 week and 12 months prior to recruitment.
• Attending Coathill Hospital (NHS Lanarkshire) for stroke rehabilitation which includes gait training.
• Have Hemiplegia.
• Medically Stable.
• Able to follow simple, verbal instructions in English, or in another language if an appropriate translator is available.
• Able to provide informed consent.

You may not qualify if:

• Considered by the GP or NHS clinicians to be unsafe to do mild exercise for the duration of time required (about 20 minutes).
• Have contracture of the hip, knee or ankle which prevents walking.
• Have any skin irritation on the shank.
• Have a cardiac pacemaker.
• A body mass that exceeds the capacity of the equipment (\>100Kg).
• Cognitive impairment severe enough to prevent adherence with the protocol (assessed by the clinicians responsible for each volunteer).
• Walking difficulty before stroke (for example, patients who had history of severe spinal stenosis or peripheral vascular diseases)

Sponsors & Collaborators

• University of Strathclyde: lead

Study Sites (1)

Coathill Hospital

Coatbridge, Lanarkshire, ML5 4DN, United Kingdom

Location

Related Publications (1)

• Phongamwong C, Rowe P, Chase K, Kerr A, Millar L. Treadmill training augmented with real-time visualisation feedback and function electrical stimulation for gait rehabilitation after stroke: a feasibility study. BMC Biomed Eng. 2019 Aug 22;1:20. doi: 10.1186/s42490-019-0020-1. eCollection 2019.

  PMID: 32903355 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrew Kerr, PhD

  University of Strathclyde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The primary gait measure (number of daily steps in teh community) will be collected by an independent assessor.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a singles subject design with participants acting as their own control. Control data being recorded during the week before the intervention begins

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: November 20, 2017
• Study Start: June 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: October 31, 2019
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)