Dataset Information

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).

ABSTRACT:

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.

SUBMITTER: Kottink AIR

PROVIDER: S-EPMC9019626 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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).

Kottink Anke Ida Roza AIR Nikamp Corien Dm CD Bos Foskea P FP van der Sluis Corry K CK van den Broek Marieke M Onneweer Bram B Stolwijk-Swüste Janneke M JM Brink Sander M SM Voet Nicoline Bm NB Buurke Jacob B JB Rietman Johannes S JS Prange-Lasonder Gerdienke B GB

JMIR research protocols 20220405 4

<h4>Background</h4>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.<h4>Objective</h4>We aim to investigate the therapeutic effec ...[more]

PMID: 35380115

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Project description:BackgroundSoft-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.ObjectiveTo evaluate the therapeutic effect of a grip-supporting soft-robotic glove as an assistive device at home during daily activities.MethodsThis 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.Results63 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.ConclusionThe 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.

Project description:BackgroundSpinal cord injury is a devastating condition that can dramatically impact hand motor function. Passive and active assistive devices are becoming more commonly used to enhance lost hand strength and dexterity. Soft robotics is an emerging discipline that combines the classical principles of robotics with soft materials and could provide a new class of active assistive devices. Soft robotic assistive devices enable a human-robot interaction facilitated by compliant and light-weight structures. The scope of this work was to demonstrate that a fabric-based soft robotic glove can effectively assist participants affected by spinal cord injury in manipulating objects encountered in daily living.MethodsThe Toronto Rehabilitation Institute Hand Function Test was administered to 9 participants with C4-C7 spinal cord injuries to assess the functionality of the soft robotic glove. The test included object manipulation tasks commonly encountered during activities of daily living (ADL) and lift force measurements. The test was administered to each participant twice; once without the assistive glove to provide baseline data and once while wearing the assistive glove. The object manipulation subtests were evaluated using a linear mixed model, including interaction effects of variables such as time since injury. The lift force measures were separately evaluated using the Wilcoxon signed-rank test.ResultsThe soft robotic glove improved object manipulation in ADL tasks. The difference in mean scores between baseline and assisted conditions was significant across all participants and for all manipulated objects. An improvement of 33.42 ± 15.43% relative to the maximal test score indicates that the glove sufficiently enhances hand function during ADL tasks. Moreover, lift force also increased when using the assistive soft robotic glove, further demonstrating the effectiveness of the device in assisting hand function.ConclusionsThe results gathered in this study validate our fabric-based soft robotic glove as an effective device to assist hand function in individuals who have suffered upper limb paralysis following a spinal cord injury.

Project description:BackgroundChronic stroke patients usually experience reduced hand functions, impeding their ability to perform activities of daily living (ADLs) independently. Additionally, improvements in hand functions by physical therapy beyond six months after the initial onset of stroke are much slower than in the earlier months. As such, chronic stroke patients could benefit from an assistive device to enhance their hand functions, allowing them to perform ADLs independently daily. In recent years, soft robotics has provided a novel approach to assistive devices for motor impaired individuals, offering more compliant and lightweight alternatives to traditional robotic devices. The scope of this study is to demonstrate the viability of a fabric-based soft robotic (SR) glove with bidirectional actuators in assisting chronic stroke study participants with hand impairments in performing ADLs.MethodsForce and torque measurement tests were conducted to characterize the SR Glove, and hand functional tasks were given to eight chronic stroke patients to assess the efficacy of the SR Glove as an assistive device. The tasks involved object manipulation tasks that simulate ADLs, and the series of tasks was done by the participants once without assistance for baseline data, and once while using the SR Glove. A usability questionnaire was also given to each participant after the tasks were done to gain insight into how the SR Glove impacts their confidence and reliance on support while performing ADLs.ResultsThe SR Glove improved the participants' manipulation of objects in ADL tasks. The difference in mean scores between the unassisted and assisted conditions was significant across all participants. Additionally, the usability questionnaire showed the participants felt more confident and less reliant on support while using the SR Glove to perform ADLs than without the SR Glove.ConclusionsThe results from this study demonstrated that the SR Glove is a viable option to assist hand function in chronic stroke patients who suffer from hand motor impairments.

Project description:Various robotic exoskeletons have been proposed for hand function assistance during activities of daily living (ADL) of stroke survivors. However, traditional exoskeletons involve the use of complex rigid systems that impede the natural movement of joints, and thus reduce the wearability and cause discomfort to the user. The objective of this paper is to design and evaluate a soft robotic glove that is able to provide hand function assistance using fabric-reinforced soft pneumatic actuators. These actuators are made of silicone rubber which has an elastic modulus similar to human tissues. Thus, they are intrinsically soft and compliant. Upon air pressurization, they are able to support finger range of motion (ROM) and generate the desired actuation of the finger joints. In this work, the soft actuators were characterized in terms of their blocked tip force, normal and frictional grip force outputs. Combining the soft actuators and flexible textile materials, a soft robotic glove was developed for grasping assistance during ADL for stroke survivors. The glove was evaluated on five healthy participants for its assisted ROM and grip strength. Pilot test was performed in two stroke survivors to evaluate the efficacy of the glove in assisting functional grasping activities. Our results demonstrated that the actuators designed in this study could generate desired force output at a low air pressure. The glove had a high kinematic transparency and did not affect the active ROM of the finger joints when it was being worn by the participants. With the assistance of the glove, the participants were able to perform grasping actions with sufficient assisted ROM and grip strength, without any voluntary effort. Additionally, pilot test on stroke survivors demonstrated that the patient's grasping performance improved with the presence and assistance of the glove. Patient feedback questionnaires also showed high level of patient satisfaction and comfort. In conclusion, this paper has demonstrated the possibility of using soft wearable exoskeletons that are more wearable, lightweight, and suitable to be used on a daily basis for hand function assistance of stroke survivors during activities of daily living.

Dataset Information

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

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

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).

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