Physiotherapy in Order to Improve Walking Capacity and Participation in Chronic Stroke Subjects
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cardiovascular and task-oriented training
Upper limb strength training program
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Chronic stroke, Participation, Walking ability
Eligibility Criteria
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
Sites / Locations
- University of Valencia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cardiovascular/task-oriented training
Upper limb strength training program
Arm Description
8 cardiovascular exercises at moderate intensity, interrupted by 1-minute active breaks of task-oriented exercises.
Nine 5-minute station circuit session. Patients work 2+2 minutes in each exercise, with a 30-second rest between the 2-minute periods and between stations.
Outcomes
Primary Outcome Measures
Participation (Frenchay Activities Index (FAI))
Frenchay Activities Index (FAI)
Secondary Outcome Measures
Walking ability
6 min-walk
Upper limb function (Fugl-Meyer Assessment)
Fugl-Meyer Assessment
Full Information
NCT ID
NCT02543450
First Posted
September 3, 2015
Last Updated
August 27, 2020
Sponsor
University of Valencia
Collaborators
Nueva Opción Brain Damage Association
1. Study Identification
Unique Protocol Identification Number
NCT02543450
Brief Title
Physiotherapy in Order to Improve Walking Capacity and Participation in Chronic Stroke Subjects
Official Title
Two Different Physiotherapy Programs in Order to Improve Walking Capacity and Participation in Chronic Stroke Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
Nueva Opción Brain Damage Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Chronic stroke, Participation, Walking ability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiovascular/task-oriented training
Arm Type
Experimental
Arm Description
8 cardiovascular exercises at moderate intensity, interrupted by 1-minute active breaks of task-oriented exercises.
Arm Title
Upper limb strength training program
Arm Type
Active Comparator
Arm Description
Nine 5-minute station circuit session. Patients work 2+2 minutes in each exercise, with a 30-second rest between the 2-minute periods and between stations.
Intervention Type
Other
Intervention Name(s)
Cardiovascular and task-oriented training
Intervention Type
Other
Intervention Name(s)
Upper limb strength training program
Primary Outcome Measure Information:
Title
Participation (Frenchay Activities Index (FAI))
Description
Frenchay Activities Index (FAI)
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
Walking ability
Description
6 min-walk
Time Frame
At 3 months
Title
Upper limb function (Fugl-Meyer Assessment)
Description
Fugl-Meyer Assessment
Time Frame
At 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sánchez-Sánchez ML
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
27760505
Citation
Sanchez-Sanchez ML, Ruescas-Nicolau MA, Perez-Miralles JA, Marques-Sule E, Espi-Lopez GV. Pilot randomized controlled trial to assess a physical therapy program on upper extremity function to counteract inactivity in chronic stroke. Top Stroke Rehabil. 2017 Apr;24(3):183-193. doi: 10.1080/10749357.2016.1245395. Epub 2016 Oct 19.
Results Reference
derived
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Physiotherapy in Order to Improve Walking Capacity and Participation in Chronic Stroke Subjects
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