Background: With advances in technology, the adoption of wearable devices has become a viable adjunct in poststroke rehabilitation. Regaining ambulation is a top priority for an increasing number of stroke survivors. However, despite an increase in research exploring these devices for lower limb rehabilitation, little is known of the effectiveness.
Objective: This review aims to assess the effectiveness of lower limb wearable technology for improving activity and participation in adult stroke survivors.
Methods: Randomized controlled trials (RCTs) of lower limb wearable technology for poststroke rehabilitation were included. Primary outcome measures were validated measures of activity and participation as defined by the International Classification of Functioning, Disability and Health. Databases searched were MEDLINE, Web of Science (Core collection), CINAHL, and the Cochrane Library. The Cochrane Risk of Bias Tool was used to assess the methodological quality of the RCTs.
Results: In the review, we included 11 RCTs with collectively 550 participants at baseline and 474 participants at final follow-up including control groups and participants post stroke. Participants’ stroke type and severity varied. Only one study found significant between-group differences for systems functioning and activity. Across the included RCTs, the lowest number of participants was 12 and the highest was 151 with a mean of 49 participants. The lowest number of participants to drop out of an RCT was zero in two of the studies and 19 in one study. Significant between-group differences were found across three of the 11 included trials. Out of the activity and participation measures alone, P values ranged from P=.87 to P ≤.001.
Conclusions: This review has highlighted a number of reasons for insignificant findings in this area including low sample sizes, appropriateness of the RCT methodology for complex interventions, a lack of appropriate analysis of outcome data, and participant stroke severity.
The worldwide incidence of stroke is set to escalate from 15.3 million to 23 million by 2030 . In the United Kingdom, strokes are the largest single cause of disability [ ] resulting in a cost to the economy of £8.9 billion a year [ ]. It is estimated that following a stroke, only 15% will gain complete functional recovery for both the upper and lower extremities [ ] with walking and mobility being key issues for many stroke survivors who report the importance of regaining mobility [ ]. However, with the ever-increasing financial challenges facing the National Health Service (NHS), service needs cannot be met. Therefore, utilizing information and communication technology together with the implementation of well-evidenced medical technologies is essential for continued rehabilitation for stroke survivors.
The adoption of technological solutions can facilitate patient and caregiver empowerment and a paradigm shift in control and decision making to that of a shared responsibility and self-management . It also has the potential to reduce the administrative burden for care professionals and support the development of new interventions [ ]. Incorporating technology into the daily lives of stroke survivors is a key objective in safeguarding a better quality of life for them.
Evidence exists supporting the need for intensity and repetition of motor skills in order to promote neuroplasticity and motor relearning . A number of technological aids with a potential to enhance poststroke motor recovery has been explored [ ]. However, many include the use of expensive, large, complex, cumbersome apparatus that necessitates the therapist to be present during use [ ]. Therefore inexpensive, externally wearable, commercially available sensors have become a more viable option for independent home-based poststroke rehabilitation [ ].
Recent systematic and non-systematic reviews highlight the growing use of externally wearable devices to augment poststroke rehabilitation in both clinical and non-clinical settings for motion analysis and physical activity monitoring [– ]. These include microelectromechanical systems containing accelerometers, gyroscopes, and magnetometers; fabric and body-worn sensor networks [ ]; and physiological monitoring such as blood pressure and oxygen saturation [ , ]. Other wearable devices specifically designed and used for poststroke rehabilitation also include robotics [ ], virtual reality [ ], Functional Electrical Stimulation (FES) [ ], electromyographic biofeedback (EMG-BFB) [ ], and Transcutaneous Electrical Nerve Stimulation (TENS) [ , ].
However, while these devices have the potential to reliably measure duration, frequency, intensity, and quality of activity and movement, all of which are key variables for poststroke recovery , no reviews have synthesized the effectiveness of these devices for poststroke lower-limb rehabilitation.
The International Classification of Functioning, Disability and Health (ICF)  considers the interaction between pathology (body structure and function), impairment (signs and symptoms), activities (functionality), and participation (social integration) and has now become the main conceptual framework for poststroke rehabilitation [ – ]. For this review, we focused on the activities and participation domain of the ICF as this would provide an indication of how the interventions have or have not led to functional gains in everyday life, which is the rehabilitation goal for both clinicians and stroke survivors [ ].
Therefore, the aim of this review was to examine how effective external wearable devices are as interventions for improving function of the lower limb in adult stroke survivors.
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