University of Ottawa
Ottawa, Ontario, Canada
NCT Number: NCT03191422
This study aims to explore if the LSVT BIG® - a motor learning based treatment program designed for rehabilitation of people with Parkinson's disease could be beneficial for chronic stroke rehabilitation. A single-case experimental design with two adult participants, will be monitored for performance on self-selected goals before, during and after participating in the treatment program.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Ottawa, Ontario, Canada
Over 700 000 Canadians are living with the effects of stroke. Approximately 60% of people living with the effects of stroke need help with every day activities and 84% are limited in the activities which they would like to participate in. Much research has focused on interventions for acute and sub-acute rehabilitation but it is also known that gains can still be made in the chronic stage. Among common rehabilitation interventions to reduce impairment, there is moderate evidence of effectiveness of constraint induced movement therapy (CIMT) and mirror therapy and weak evidence of effectiveness of repetitive task training. However, positive effects on impairment do not necessarily carryover into activities of daily living.
Therefore, an intervention program with a goal of improvement in occupational performance outside of the clinical setting, one that targets everyday activities and participant selected activities, would be a valuable tool for occupational therapy post stroke. The objective of this study was to explore whether the LSVT BIG® program, an intervention targeting participant-identified functional goals which includes strategies to encourage generalization to other tasks, could be applicable to the rehabilitation of the chronic effects of stroke.
LSVT BIG is a time limited, high intensity rehabilitation program designed to be used by occupational therapists or physiotherapists to target Parkinson's disease motor symptoms of bradykinesia and hypokinesia, in an outpatient environment, with a goal of improving function. This intervention involves exercises and repetitive practice of patient-selected activities with a focus on big (increased amplitude) movements. It is believed that this will lead to normally paced and sized movements which will generalize to untrained activities.
Although Parkinson's disease and stroke have different pathological mechanisms, the elements in the LSVT BIG program are based on the same neuroplasticity and motor learning principles that form the basis for stroke rehabilitation methods. What is novel, however, is the focus on amplitude and just one cue, 'big', for all difficult movement situations, potentially increasing generalizability outside of the clinical setting and trained activities.
The LSVT BIG program uses motor learning principles of blocked practice, serial practice and elements of random practice (varying environmental factors), extrinsic feedback (including verbal feedback, modeling, shaping and focus on knowledge of results) as well as a single external, knowledge of results focused cue 'big' to encourage adaptation, recalibration of the internal motor program of the movement, and transfer to other tasks. LSVT BIG also respects the neuroplasticity principles of intensity, repetition, specificity and saliency The aim of this study is to begin to explore the effectiveness of LSVT BIG in late stroke rehabilitation.
The primary hypothesis is that participants with chronic stroke will demonstrate improvement in trained activities following LSVT BIG.
A secondary hypothesis is that participants will also improve in untrained activities due to carryover of the intervention effects.
Study Design A single-case experimental design (SCED) with one replication was used . An A-B-A design was selected and included a baseline phase, an intervention phase, and a post-intervention phase. Perceived performance and satisfaction with performance of participant-selected activities, and self-report of everyday upper extremity use were the outcomes subjected to repeated measures. In addition, pre- and post- measures of observed performance quality and upper extremity function were carried out.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
LSVT BIG is a motor learning based intervention 4 hour long sessions per week for 4 weeks following a specific protocol. Each session is composed of exercises and participant specific activities, as well as a homework program.
Time frame: Administered weekly, for 6 weeks pre-intervention, 4 weeks during intervention and 5 post-intervention
Positive change on performance score using the Canadian Occupational Performance Measure (COPM)
Time frame: Administered weekly, for 6 weeks pre-intervention, 4 weeks during intervention and 5 post-intervention
Positive change in perceived upper extremity use using the Rating of Everyday Arm-Use in the Community and Home (REACH)
Time frame: Administered at week 1 and week 10
Positive change in objective rating of activity performance using the Performance Quality Rating Scale- Operational Definition (PQRS-OD),
Time frame: Administered at week 1 and week 10
Positive change in upper extremity function as measured by the Chedoke Arm and Hand Activity Inventory-13(CAHAI-13)
University of Ottawa
Other
LSVT BIG for Chronic Stroke Rehabilitation: a Single-Case Experimental Design
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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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