Visual Cues for Gait Training Post-stroke (VCTpilot)

University of Salford

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Treadmill visual cue training; Behavioral: Usual care; Behavioral: Overground visual cue training

Study type: Interventional

Funder types: Other

Identifiers

NCT01600391

VCTpilot

Details and patient eligibility

About

Given that visual information comprises one of the most important and salient sources of information used during walking, that visual cues have been shown to be more effective than auditory cues in triggering gait adjustments and that stroke survivors have been reported to become more dependent on visual cues, the investigators hypothesize that visual cues would be more effective in triggering gait recovery and adaptability following stroke than interventions not including visual cues.

The investigators will integrate visual cues with walking and turning practice, and contrast this intervention to routine overground walking practice. Stroke participants recruited from NHS stroke rehabilitation clinics in the West Midlands, will be randomized to one of three gait rehabilitation groups. Each group will receive the same frequency and duration of treatment delivered by qualified physiotherapists. Overground visual cue training (OVCT) and usual care (UC) groups will be treated in participating NHS sites. Treadmill training with visual cues (TVCT) will take place at the University of Birmingham.

Full description

The gait of many stroke patients remains impoverished and characterized by impairments including asymmetries in propulsive forces between the paretic and non-paretic limbs, step lengths, widths and stance and swing phase durations. Currently there is insufficient evidence that current rehabilitation strategies improve walking in people who are more than 6 months post-stroke.

The purpose of the trial is to determine the necessary information on which to base a future definitive trial examining the effectiveness of visual cues for gait training following stroke in contrast to conventional over-ground walking practice.

The study will determine the numbers of patients willing to be recruited into both control and VCT groups; the willingness of physiotherapists at each collaborating site to enroll patients to usual care OVCT and TVCT groups.

It will determine the numbers of patients who do not complete the allocated treatment, thus dropping out of the study, and the reasons for dropping out.

The knowledge gathered about recruitment, outcomes and drop-out rates will determine sample size for a subsequent definitive trial.

The study will also measure completeness of outcome data, i.e. percentage of patients with no missing values in outcome assessments.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of stroke
• Able to walk 10 metres with or without assistance
• Residual paresis in the lower limb (Fugl-Meyer Lower Limb score less than 34)
• Informed written consent.

Exclusion criteria

• Gait speed more than 0.8 m/s
• Patients with a premorbid (retrospective) modified Rankin Scale score of greater than 3
• Gait deficits attributable to non-stroke pathology
• Visual impairments preventing use of visual cue training (as assessed by Apple Cancellation test
• Concurrent progressive neurologic disorder, acute coronary syndrome, severe heart failure, confirmed or suspected lower-limb fracture preventing mobilization, and those requiring palliative care
• Inability to follow a three step command (as assessed by Modified mini-mental status exam).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Usual Care

Active Comparator group

Description:

A task specific-based intervention that does not include use of visual cues to influence quality or adaptability of gait.

Treatment:

Behavioral: Usual care

Overground visual cue training

Experimental group

Description:

Overground visual cue training will involve stepping to targets which are positioned to improve gait symmetry and speed. Training will include turning practice and the avoidance of obstacles for adaptability during straight walking.

Treatment:

Behavioral: Overground visual cue training

Treadmill visual cue training

Experimental group

Description:

Treadmill training with visual cues will be delivered using a force-instrumented treadmill (CMill, Forcelink, NL). Walking training will involve stepping to targets which are positioned to improve gait symmetry and speed. Training will include turning practice and the avoidance of obstacles for adaptability during straight walking.

Treatment:

Behavioral: Treadmill visual cue training