NCT03104127

Brief Summary

This study will investigate if a lower limb robotic device can be used in a community setting to increase the amount of physical activity that individuals undertake following stroke and consequently improve biomechanical, physiological and health outcomes, in patients with stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

April 24, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2.2 years

First QC Date

March 2, 2017

Last Update Submit

January 16, 2020

Conditions

Gait, HemiplegicQuality of LifeVascular StiffnessStroke

Keywords

Lower-limb robotic deviceGaitBalancePressureChronic strokeBlood pressureBlood velocityAerobic fitnessStrength

Outcome Measures

Primary Outcomes (3)

  • Change from baseline Gait analysis at 10-weeks post-intervention

    Eight Qualisys cameras (six Oqus 3+, two Oqus 5+, Goteborg, Sweden) will be used to measure joint angles, rotations, hip obliquity, segment accelerations and velocities. Six Degrees or Fredom 6DoF 27 point marker set will be used and joint centres identified through palpation. The participants will be asked to walk for 6 meters for minimum of three trials in order to obtain walking gait patterns.

    Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each gait analysis assessment will take 30 minutes

  • Change from baseline Gait analysis at 10-weeks post-intervention

    The participants will be asked to walk for 6 meters, over a pressure mat (RSscan Footscan, Ipswitch, UK), for minimum of three trials in order to obtain walking gait patterns.

    Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each gait analysis assessment will take 30 minutes

  • Change from baseline Gait analysis at 10-weeks post-intervention

    A BTS G-Walk (Brooklyn, New York) sensor will also be worn by the participants to collect additional spatio-temporal gait parameters(cadence, speed, stride/step length, stance/swing phase duration, single/double support duration and pelvic girdle angles).

    aseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each gait analysis assessment will take 30 minutes

Secondary Outcomes (10)

  • Timed-up-and-go

    Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. The timed-up-and-go assessment will take 10 minutes

  • Ashworth scale

    Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 10 minutes

  • Body mass

    Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes

  • Central and peripheral blood pressures

    Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes following 20 minutes supine rest.

  • Arterial stiffness and blood velocity of the carotid artery

    Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes following 20 minutes supine rest.

  • +5 more secondary outcomes

Other Outcomes (8)

  • Dynamic gait index

    Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up

  • Berg Balance

    Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up

  • Balance Confidence Scale

    Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up

  • +5 more other outcomes

Study Arms (3)

Alter G Bionic Leg

EXPERIMENTAL

Participants randomised to a group including normal therapy (physiotherapy) and the use of a Alter G robotic bionic leg. All participants have previously completed normal NHS therapy.

Device: Alter G Bionic LegOther: Normal therapy (physiotherapy)

Normal therapy

ACTIVE COMPARATOR

Participants randomised to a group including normal therapy (physiotherapy) only. All participants have previously completed normal NHS therapy.

Other: Normal therapy (physiotherapy)

Usual care

NO INTERVENTION

Have completed normal NHS therapy and no longer (\> 6 months) receive active physiotherapy.

Interventions

Alter G Bionic LegDEVICE

Participants are randomized to a 10 week, community-based bionic leg programme. Participants must use the leg for a minimum of 1 hour per day and continue to have active physical therapy sessions.

Alter G Bionic Leg
Normal therapy (physiotherapy)OTHER

Participants are randomized to a normal therapy (physiotherapy) only program. Participants are also advised to undertake 1 hour a day of physical activity and have active physical therapy (physiotherapy) sessions.

Alter G Bionic LegNormal therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diagnosis of stroke within 3-60 months
  • Community patients that are medically stable and currently receiving therapeutic input from Hobbs Rehabilitation
  • Individuals who are able to stand and step with an aid or assistance
  • Cognitively aware of task demands
  • Height: 5ft 2-6ft 3 (158-192 cm)
  • Weight: \<25 stone (\< 159kg)

You may not qualify if:

  • Unresolved deep vein thrombosis
  • Unstable cardiovascular conditions
  • Open wounds
  • Active drug resistant infection
  • Recent fractures of involved limb
  • Peripheral arterial disease
  • Incontinence
  • Severe osteoporosis
  • Non weight bearing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Winchester

Winchester, Hampshire, SO22 4NR, United Kingdom

Location

Related Publications (1)

  • Faulkner J, Wright A, Stone K, Fryer S, Martinelli L, Lambrick D, Paine E, Stoner L. Effect of home-based, overground robotic-assisted gait training on vascular health in people with chronic stroke. Front Neurol. 2023 Mar 10;14:1093008. doi: 10.3389/fneur.2023.1093008. eCollection 2023.

    PMID: 36970545DERIVED

MeSH Terms

Conditions

Gait Disorders, NeurologicStroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • James Faulkner, PhD

    University of Winchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2017

First Posted

April 7, 2017

Study Start

April 24, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)