Therapy effect on hand function after home use of a wearable assistive soft-robotic glove supporting grip strength.

BACKGROUND: Soft-robotic gloves with an assist-as-needed control have the ability to assist daily activities where needed, while stimulating active and highly functional movements within the user's possibilities. Employment of hand activities with glove support might act as training for unsupported hand function. OBJECTIVE: To evaluate the therapeutic effect of a grip-supporting soft-robotic glove as an assistive device at home during daily activities. METHODS: This multicentre intervention trial consisted of 3 pre-assessments (averaged if steady state = PRE), one post-assessment (POST), and one follow-up assessment (FU). Participants with chronic hand function limitations were included. Participants used the Carbonhand glove during six weeks in their home environment on their most affected hand. They were free to choose which activities to use the glove with and for how long. The primary outcome measure was grip strength, secondary outcome measures were pinch strength, hand function and glove use time. RESULTS: 63 patients with limitations in hand function resulting from various disorders were included. Significant improvements (difference PRE-POST) were found for grip strength (+1.9 kg, CI 0.8 to 3.1; p = 0.002) and hand function, as measured by Jebson-Taylor Hand Function Test (-7.7 s, CI -13.4 to -1.9; p = 0.002) and Action Research Arm Test (+1.0 point, IQR 2.0; p≤0.001). Improvements persisted at FU. Pinch strength improved slightly in all fingers over six-week glove use, however these differences didn't achieve significance. Participants used the soft-robotic glove for a total average of 33.0 hours (SD 35.3), equivalent to 330 min/week (SD 354) or 47 min/day (SD 51). No serious adverse events occurred. CONCLUSION: The present findings showed that six weeks use of a grip-supporting soft-robotic glove as an assistive device at home resulted in a therapeutic effect on unsupported grip strength and hand function. The glove use time also showed that this wearable, lightweight glove was able to assist participants with the performance of daily tasks for prolonged periods.

Effect on Hand Function After Six-week Use of a Wearable Soft-Robotic Glove Assisting ADL: Interim Results of an Ongoing Clinical Study.

In an ongoing study, an assistive wearable soft-robotic glove is tested at home for 6 weeks by subjects with decreased handgrip strength, due to different hand injuries or diseases, to assess whether use of this assistive grip-supporting glove will result in improved hand strength/ function. An interim analysis of the available dataset of 46 participants showed that (unsupported) grip strength and hand function improved after using the soft-robotic glove as assistive aid during activities of daily living (ADLs) during 6 weeks at home. After glove use is ended, this is maintained for at least 4 weeks. Considering that in the current situation the analysis is underpowered, these interim results are promising for finding a clinical (therapeutic) effect of using a soft-robotic glove as assistance during ADLs. If this is the case, this might open up entirely new opportunities for extending rehabilitation into people's homes, while also providing them with assistance to directly support performance of daily activities. Such a combination is becoming available with the development of mature and user-friendly wearable soft-robotic devices. This would enable very high doses of training throughout the day, in the most functional, task-specific way possible, and possibly prevention of learned non-use.

The effect of ankle-foot orthoses on fall/near fall incidence in patients with (sub-)acute stroke: A randomized controlled trial.

Falls are commonly reported post-stroke. Ankle-foot orthoses (AFOs) are often provided to improve safety and walking, but the effect of their use in the reduction of falls after stroke is unknown. A randomized controlled trial (RCT) on the effects of AFO-provision after stroke was performed. Effects on clinical scales, 3D-gait kinematics and muscle-activity were previously reported. This paper aims to study the effects of AFO-provision on occurrence and circumstances of falls/near falls. The RCT included unilateral hemiparetic stroke patients. AFOs were provided either early (study week 1) or delayed (study week 9). Both groups were compared in the first eight weeks of the study and diaries were used to register falls/near falls and their circumstances. Follow-up measurements were performed in week 9-52, in which both groups were provided with AFOs. Functional Ambulation Categories and Berg Balance Scale were assessed to determine walking independence and balance, respectively. Last known scores were noted in case of an incident. Thirty-three subjects were included (16 early, 17 delayed). In week 1-8, the early group, who were provided with AFOs, fell significantly more frequently compared with the delayed group, 11 versus 4 times, respectively (Incidence Rate Ratio = 2.9, p = 0.039). Out of the falls recorded in the early group, 63.6% occurred without wearing AFOs. Most of these falls occurred during transfers (36.4%) and standing (27.3%), and notably it were the subjects who did not have independent walking ability. No differences were found for near falls in week 1-8, or for falls/near falls in week 9-52. Six severe consequences (including fractures) were reported from a fall. To conclude, the subjects provided with AFOs early after stroke reported a higher number of falls, compared to the subjects that had not yet been provided with AFOs. However, in the subjects provided with AFOs, 63.6% of the falls occurred whilst without wearing the AFO. Furthermore, the majority of these incidents took place whilst subjects had no independent walking ability. This raises an interesting question of the importance of careful instructions to patients and their relatives, and the influence of potential cognitive impairments on the ability of the subjects to take on these instructions.

The influence of early or delayed provision of ankle-foot orthoses on pelvis, hip and knee kinematics in patients with sub-acute stroke: A randomized controlled trial.

BACKGROUND: Compensatory pelvis, hip- and knee movements are reported after stroke to overcome insufficient foot-clearance. Ankle-foot orthoses (AFOs) are often used to improve foot-clearance, but the optimal timing of AFO-provision post-stroke is unknown. Early AFO-provision to prevent foot-drop might decrease the development of compensatory movements, but it is unknown whether timing of AFO-provision affects post-stroke kinematics. RESEARCH QUESTIONS: 1) To compare the effect of AFO-provision at two different points in time (early versus delayed) on frontal pelvis and hip, and sagittal hip and knee kinematics in patients with sub-acute stroke. Effects were assessed after 26 weeks; 2) To study whether possible changes in kinematics or walking speed during the 26-weeks follow-up period differed between both groups. METHOD: An explorative randomized controlled trial was performed, including unilateral hemiparetic patients maximal six weeks post-stroke with indication for AFO-use. Subjects were randomly assigned to AFO-provision early (at inclusion) or delayed (eight weeks later). 3D gait-analysis with and without AFO was performed in randomized order. Measurements were performed in study-week 1, 9, 17 and 26. RESULTS: Twenty-six subjects (15 early, 11 delayed) were analyzed. After 26 weeks, no differences in kinematics were found between both groups for any of the joint angles, both for the without and with AFO-condition. Changes in kinematics during the 26-weeks follow-up period did not differ between both groups for any of the joint angles during walking without AFO. Significant differences in changes in walking speed during the 26-weeks follow-up were found (p = 0.034), corresponding to the first eight weeks after AFO-provision. SIGNIFICANCE: Results indicate that early or delayed AFO-use post-stroke does not influence pelvis, hip and knee movements after 26 weeks, despite that AFO-use properly corrected drop-foot. AFOs should be provided to improve drop-foot post-stroke, but not with the intention to influence development of compensatory patterns around pelvis and hip.

A randomized controlled trial on providing ankle-foot orthoses in patients with (sub-)acute stroke: Short-term kinematic and spatiotemporal effects and effects of timing.

Initial walking function is often limited after stroke, and regaining walking ability is an important goal in rehabilitation. Various compensatory movement strategies to ensure sufficient foot-clearance are reported. Ankle-foot orthoses (AFOs) are often prescribed to improve foot-clearance and may influence these strategies. However, research studying effects of actual AFO-provision early after stroke is limited. We conducted an explorative randomized controlled trial and aimed to study the short-term effects of AFO-provision on kinematic and spatiotemporal parameters in patients early after stroke. In addition, we studied whether timing of AFO-provision influenced these effects. Unilateral hemiparetic patients maximal six weeks post-stroke were randomly assigned to AFO-provision: early (at inclusion) or delayed (eight weeks later). Three-dimensional gait-analysis with and without AFO in randomized order was performed within two weeks after AFO-provision. Twenty subjects (8 early, 12 delayed) were analyzed. We found significant positive effects of AFO-provision for ankle dorsiflexion at initial contact, foot-off and during swing (-3.6° (7.3) vs 3.0° (3.9); 0.0° (7.4) vs 5.2° (3.7); and -6.1° (7.8) vs 2.6° (3.5), respectively), all p<0.001. No changes in knee, hip and pelvis angles were found after AFO-provision, except for knee (+2.3°) and hip flexion (+1.6°) at initial contact, p≤0.001. Significant effects of AFO-provision were found for cadence (+2.1 steps/min, p=0.026), stride duration (-0.08s, p=0.015) and single support duration (+1.0%, p=0.002). Early or delayed AFO-provision after stroke did not affect results. In conclusion, positive short-term effects of AFO-provision were found on ankle kinematics early after stroke. Timing of AFO-provision did not influence the results. TRIAL REGISTRATION NUMBER: NTR1930.