Clinical trial NCT06033027: Arm Use With Soft-robotic Glove
Official title: Influence of Assistive Soft-robotic Glove Use on Actual Arm Use in Daily Life
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Trauma Injury of Hand Multiple
Neurologic Disorder
Lead sponsor: Roessingh Research and Development
Sponsor class: OTHER
Collaborators: name: Eurostars
First posted: 2023-09-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single case experimental design with multiple baselines
Primary purpose: OTHER

Brief summary: This study, aimed at investigating the impact of using a supportive soft-robotic glove on actual arm and hand use in daily life, is designed as a single-case experimental design study. 3-5 patients with limitations in hand function due to trauma-related or neurological conditions are asked to participate. Participants will be asked to use a soft-robotic glove at home for six weeks during daily activities relevant to them, while that glove supports the grip of their most affected hand. For several weeks before, during and after the use of the soft-robotic glove, participants will be asked to do some short tests (wearing an activity meter on both wrists during the day, performing a hand squeeze test under the supervision of the researcher via video call) and to answer some questions related to perceived hand function and well-being (a total of at least 15 times during 12-14 weeks). The present study is a follow-up to previous studies that investigated the effect of (previous versions of) the same robotic glove (Carbonhand; Bioservo Technolo-gies AB, Kista, Sweden) on hand function, in order to better understand and explain the observed therapeutic effect.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 90 years
* Experience difficulties in performing ADL due to hand function limitations as a result of trauma-related injury or neurologic disorder
* Being in a chronic/stable phase of disease as judged by their physician
* Able to activate the soft-robotic glove by generating pressure on finger/palm sensors when grasping an object
* Ability to relax an active grip
* Sufficient cognitive status to understand two-step instructions
* Having (corrected to) normal vision
* Able to provide written informed consent
* Living independently

Exclusion Criteria:

* Severe sensory problems of the most-affected hand
* Severe acute pain of the most-affected hand
* Wounds on the hands that can provide a problem when using the glove
* Severe contractures limiting passive range of motion to the extent that the glove can't be donned/activated comfortably
* Co-morbidities limiting functional use/performance of the arms and/or hands
* Severe spasticity of the hand (≥2 points on Ashworth Scale)
* Severe proximal weakness (MRC shoulder elevation\<4)
* Used the Carbonhand system in the past 3 months
* Participation in other studies that can affect functional performance of the arm/hand
* Receiving arm-/hand function therapy during the course of the study
* Insufficient digital literacy to conduct video calls
* Insufficient knowledge of the Dutch or English language to understand the purpose or methods of the study

Primary outcomes:
measure: Actual arm activity
timeFrame: During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases), while wearing the MotionWatch for a day during waking hours (ca. 12h).
Secondary outcomes:
measure: Grip strength
timeFrame: During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases), with supervision by researcher on videocall
measure: Michigan Hand Outcomes Questionnaire - Question 2 (MHQ-Q2)
timeFrame: During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases)
measure: Positive Health questionnaire
timeFrame: During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases)
measure: Glove use data
timeFrame: Continuously and automatically during soft-robotic glove use phase (6 weeks) when soft-robotic glove is turned on and activated.
measure: Diary
timeFrame: Continuously during soft-robotic glove use phase (6 weeks) when soft-robotic glove is used
measure: Motor Activity Log (MAL)
timeFrame: Thee times across 12-14 weeks during evaluations at the end of each study phase (between week 2-4, week 8-10, week 12-14, with exact scheduling depending on randomized length of baseline phase)
measure: Jebsen-Taylor hand function test (JTHFT)
timeFrame: Thee times across 12-14 weeks during evaluations at the end of each study phase (between week 2-4, week 8-10, week 12-14, with exact scheduling depending on randomized length of baseline phase)
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: Thee times across 12-14 weeks during evaluations at the end of each study phase (between week 2-4, week 8-10, week 12-14, with exact scheduling depending on randomized length of baseline phase)
measure: Michigan Hand Outcome Questionnaire - Dutch Language Version (MHQ-DLV)
timeFrame: Thee times across 12-14 weeks during evaluations at the end of each study phase (between week 2-4, week 8-10, week 12-14, with exact scheduling depending on randomized length of baseline phase)
measure: Euroqol-5D (EQ-5D)
timeFrame: Thee times across 12-14 weeks during evaluations at the end of each study phase (between week 2-4, week 8-10, week 12-14, with exact scheduling depending on randomized length of baseline phase)
measure: Short-Form (SF-36)
timeFrame: Thee times across 12-14 weeks during evaluations at the end of each study phase (between week 2-4, week 8-10, week 12-14, with exact scheduling depending on randomized length of baseline phase)
measure: Semi-structured interview
timeFrame: One time across 12-14 weeks during evaluation at the end of the intervention phase (between week 8-10, with exact scheduling depending on randomized length of baseline phase)
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Roessingh Research and Development
state: Overijssel
Study officials:
affiliation: Roessingh Research and Development
name: Gerdienke Prange, PhD
role: PRINCIPAL_INVESTIGATOR
References: