Therapeutic Effect of a Soft Robotic Glove for Activities of Daily Living In People With Impaired Hand Strength: Protocol for a Multicenter Clinical Trial (iHand).

BACKGROUND: Decline of hand function, especially reduced hand strength, is a common problem that can be caused by many disorders and results in difficulties performing activities of daily living. A wearable soft robotic glove may be a solution, enabling use of the affected arm and hand repeatedly during functional daily activities and providing intensive and task-specific training simultaneously with assistance of hand function. OBJECTIVE: We aim to investigate the therapeutic effect of an assistive soft robotic glove (Carbonhand). METHODS: This multicenter uncontrolled intervention study consists of 3 preassessments (T0, T1, and T2), a postassessment (T3), and a follow-up assessment (T4). Participants are patients who experience hand function limitations. For the intervention, participants will use the glove during activities of daily living at home for 6 weeks, with a recommended use of at least 180 minutes per week. The primary outcome measure is handgrip strength, and secondary outcome measures are related to functional arm and hand abilities, amount of glove use, and quality of life. RESULTS: The first participant was included on June 25, 2019. Currently, the study has been extended due to the COVID-19 pandemic; data collection and analysis are expected to be completed in 2022. CONCLUSIONS: The Carbonhand system is a wearable assistive device, allowing performance of functional activities to be enhanced directly during functional daily activities. At the same time, active movement of the user is encouraged as much as possible, which has potential to provide highly intensive and task-specific training. As such, it is one of the first assistive devices to incorporate assist-as-needed principles. This is the first powered clinical trial that investigates the unique application of an assistive grip-supporting soft robotic glove outside of clinical settings with the aim to have a therapeutic effect. TRIAL REGISTRATION: Netherlands Trial Register NTR NL7561; https://www.trialregister.nl/trial/7561. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34200.

Six-month effects of early or delayed provision of an ankle-foot orthosis in patients with (sub)acute stroke: a randomized controlled trial.

OBJECTIVE: To study the six-month clinical effects of providing ankle-foot orthoses at different moments (early or delayed) in (sub)acute stroke; this is a follow-up to a published trial. DESIGN: Randomized controlled trial. SETTING: Rehabilitation centre. SUBJECTS: Unilateral hemiparetic stroke subjects maximal six weeks post-stroke with indication for ankle-foot orthosis use. INTERVENTIONS: Subjects were randomly assigned to early (at inclusion; week 1) or delayed provision (eight weeks later; week 9). OUTCOME MEASURES: Functional tests assessing balance and mobility were performed bi-weekly for 17 weeks and at week 26. RESULTS: In all, 33 subjects were randomized. No differences at week 26 were found between both groups for any of the outcome measures. However, results suggest that early provision leads to better outcomes in the first 11-13 weeks. Berg Balance Scale ( P = 0.006), Functional Ambulation Categories ( P = 0.033) and 6-minute walk test ( P < 0.001) showed significantly different patterns over time. Clinically relevant but statistically non-significant differences of 4-10 weeks in reaching independent walking with higher balance levels were found, favouring early provision. CONCLUSION: No six-month differences in functional outcomes of providing ankle-foot orthoses at different moments in the early rehabilitation after stroke were found. Results suggest that there is a period of 11-13 weeks in which early provision may be beneficial, possibly resulting in early independent and safe walking. However, our study was underpowered. Further research including larger numbers of subjects is warranted.

Early or delayed provision of an ankle-foot orthosis in patients with acute and subacute stroke: a randomized controlled trial.

OBJECTIVE: (1) To study the effects of providing ankle-foot orthoses in subjects with (sub)acute stroke; and (2) to study whether the point in time at which an ankle-foot orthosis is provided post-stroke (early or delayed) influences these effects. DESIGN: Randomized controlled trial. SETTING: Rehabilitation centre. SUBJECTS: Unilateral hemiparetic stroke subjects with indication for use of an ankle-foot orthosis and maximal six weeks post-stroke. INTERVENTIONS: Subjects were randomly assigned to: early provision (at inclusion; Week 1) or delayed provision (eight weeks later; Week 9). OUTCOME MEASURES: 10-metre walk test, 6-minute walk test, Timed Up and Go Test, stairs test, Functional Ambulation Categories, Berg Balance Scale, Rivermead Mobility Index and Barthel Index; assessed in Weeks 1, 3, 9 and 11. RESULTS: A total of 33 subjects were randomized (16 early, 17 delayed). Positive effects of ankle-foot orthoses were found two weeks after provision, both when provided early (significant effects on all outcomes) or delayed (Berg Balance Scale p = 0.011, Functional Ambulation Categories p = 0.008, 6-minute walk test p = 0.005, Timed Up and Go Test p = 0.028). Comparing effects after early and delayed provision showed that early provision resulted in increased levels of improvement on Berg Balance Scale (+5.1 points, p = 0.002), Barthel Index (+1.9 points, p = 0.002) and non-significant improvements on 10-metre walk test (+0.14 m/s, p = 0.093) and Timed Up and Go Test (-5.4 seconds, p = 0.087), compared with delayed provision. CONCLUSIONS: We found positive effects of providing ankle-foot orthoses in (sub)acute stroke subjects that had not used these orthoses before.