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

NCT ID: NCT02543450

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-12-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cardiovascular/task-oriented training

8 cardiovascular exercises at moderate intensity, interrupted by 1-minute active breaks of task-oriented exercises.

Group Type: EXPERIMENTAL

Cardiovascular and task-oriented training

Intervention Type: OTHER

Upper limb strength training program

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.

Group Type: ACTIVE_COMPARATOR

Upper limb strength training program

Intervention Type: OTHER

Interventions

Cardiovascular and task-oriented training

Intervention Type: OTHER

Upper limb strength training program

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nueva Opción Brain Damage Association

UNKNOWN

Sponsor Role: collaborator

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

M Luz Sanchez

Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sánchez-Sánchez ML

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

University of Valencia

Valencia, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 27760505 (View on PubMed)

Other Identifiers

Stroke_Project_15

Identifier Type: -

Identifier Source: org_study_id