A robotic glove that supports ADL and therapeutic exercises

Elderly people and patients with acute (e.g. stroke) or chronic (e.g. arthritis) diseases frequently experience difficulties in performing activities of daily living (ADL) due to a decline in hand function. They often need personal and/or assistive devices to carry out ADL. However, personal assistance will not result in more independence in performing ADL while assistive devices have the potential to provide the assistance that is necessary to perform ADL independently. New technological innovations can support the functional performance of the arms and hands directly by a wearable soft robotic device assisting a person’s own function. By integrating both an assistive robotic device with exercise training, performance of ADL can be enhanced directly and/or via an improved arm and hand function after prolonged use of the hands.

The primary objective of the present study is to examine the orthotic and therapeutic effect of the ironHand (iH) system, consisting of both an assistive and therapeutic module, by elderly and diagnosed patients with hand function problems, after using the iH system for a four weeks training period at home. Secondary objectives are related to user acceptance, including usability, satisfaction, motivation and compliance.

A randomized controlled trial design will be conducted, in which both the elderly and patient population will be randomized into three groups; the iH assistive group, the iH therapeutic group and the control group. Evaluation is based on one baseline measurement and one evaluation measurement within one week after the intervention period of four weeks.

In total, twenty-seven elderly and fifteen stroke patients, with an age over 55 years, will participate in this study.

The intervention period for all three groups will last for a period of four weeks. The iH assistive group will use the wearable robotic device during ADL at home and the therapeutic iH group will use the wearable robotic device as a training tool using games via the patient user interface. Participants of the control group do not follow an intervention program. In the iH assistive group, participants are recommended to use the wearable robotic device for 180 minutes a week during ADL at home. The participants in the iH therapeutic group are recommended to train the hand 3 times a week for 60 minutes by performing game exercises while wearing the robotic device to support hand opening and strength and to control the game exercises on a screen. During the four weeks intervention period, all three groups will be monitored by a therapist.

The iH system may have a beneficial effect on hand function, by directly improving functional task performance or by using it as a training tool. It may be possible that the functional use of the hand improves, allowing people to be more active in ADL and to maintain or improve their health status. However, the exact benefit cannot be predicted, because this is the topic of the current research. The risks for the subjects are limited to a minimum. The iH system is a device that facilitates hand grip and opening as initiated by the user him/herself. It provides support only when necessary based on voluntary, active initiation by the person him/herself. Furthermore, the iH system is a so-called soft-robotics device, constructed from soft materials that are comfortable to wear and compliant with human movement. This prevents potential occurrence of pressure points for example. All movements conducted during the study will consist of arm/hand movements that normally occur in ADL and within the abilities of each individual. Additionally, all the evaluation measurements used in these studies are non-invasive and involve no risks for the subjects.

iH system may have a beneficial effect on hand function, by directly
improving functional task performance or by using it as a training tool. It may be possible that the functional use of the hand improves, allowing people to be more active in ADL and to
maintain or improve their health status.

Before the intervention period and within one week after the intervention period an evaluation session will be performed.

Participants of both the elderly and patient population (via two separate randomization procedures) will be randomized into three equal groups. Group 1 will use the iH assistive system (AS) during ADL at home (iH assistive group), group 2 will use the iH therapeutic system (TS) as a training tool at home (iH therapeutic group) and group 3 will not perform any intervention at home (control group) during the intervention period of four weeks.

In the iH assistive group, participants are recommended to use the wearable robotic device for 180 minutes a week during ADL at home. The participants in the iH therapeutic group are recommended to train the hand 3 times a week for 60 minutes by performing game exercises while wearing the robotic device to support hand opening and strength and to control the game exercises on a screen. During the four weeks intervention period, all three groups will be monitored by a therapist.