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Completed

NCT Number: NCT02543450

Physiotherapy in Order to Improve Walking Capacity and Participation in Chronic Stroke Subjects

In hemiplegic stroke patients, gait performance is affected by impaired walking endurance. Evidence has shown that higher exercise intensity improves cardiovascular fitness, while greater dose in task repetition benefits locomotor function. Therefore, the goal of this study is to examine the effect of a combined cardiovascular/task-oriented interval training programme on the walking capacity of chronic stroke individuals and the improvement in their participation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia

Valencia, 46010, Spain

About this study

Owing to the high prevalence of disability in stroke older adults, walking capacity and participation can be severely affected. According to the International Classification of Functioning, Disability and Health 2001, participation involves functioning in life. In Rehabilitation Medicine, there has been a growing concern about it as a way to assess success of treatment. However, appraisal of participation in stroke research is scarce.

In all stages after a stroke, Physiotherapy interventions in favor of intensive high repetitive task-oriented and task-specific training have obtained benefits on trained actions and activities. But, the effect of this type of treatment on the impact the disease has on patient´s participation is under investigated.

The aim of this study was to determine which kind of physiotherapy task-oriented training program could better improve participation in chronic stroke subjects: an upper limb strength training program (ULST) or a combined cardiovascular/task-oriented interval training (IT) program.

Therefore, the goal of this study is to examine the effect of a combined cardiovascular/task-oriented interval training programme on the walking capacity of chronic stroke individuals and the improvement in their participation.

A randomized single-blind controlled trial was carried out. Fourteen subjects with chronic hemiplegia resulting from stroke (onset >6m) were recruited. All participants were fully informed about the experimental procedures and the aim of the study. Written informed consent was signed by each subject prior to participate. Approval from the ethics committee of the University of Valencia was obtained for the study.

Subjects were randomly allocated to an ULST program with elastic bands (n=7) or to a cardiovascular/task-oriented IT program (n=7), focused on walking capacity. In the ULST group, a nine 5-minute station circuit session was designed. Patients work 2+2 minutes in each exercise, with a 30-second rest between the 2-minute periods and between stations. The IT program consisted of a set of 8 cardiovascular exercises at moderate intensity, interrupted by 1-minute active breaks of task-oriented exercises. Duration of both programmes was 3 months (3 sessions/week).

Participation was assessed by the Stroke Impact Scale (SIS-16) and the Frenchay Activities Index (FAI), before and after the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • More than 6 months after first stroke

Exclusion criteria

  • Functional disability not related to the aftermath of stroke
  • Participate in other rehabilitation programs

Treatment and study plan

Cardiovascular and task-oriented training

Other

Upper limb strength training program

Other

Primary outcomes

  1. Participation (Frenchay Activities Index (FAI))

    Time frame: At 3 months

    Frenchay Activities Index (FAI)

Secondary outcomes

  1. Walking ability

    Time frame: At 3 months

    6 min-walk

  2. Upper limb function (Fugl-Meyer Assessment)

    Time frame: At 3 months

    Fugl-Meyer Assessment

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Nueva Opción Brain Damage Association

Registry information

Official study title

Two Different Physiotherapy Programs in Order to Improve Walking Capacity and Participation in Chronic Stroke Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 7, 2015
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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