The primary objective of the present study is to examine the therapeutic effect of the Carbon Hand system on handgrip strength in patients with hand function problems, after using the glove for six weeks at home. Secondary objectives are related to…
ID
Source
Brief title
Synonym
Health condition
orthopedic disorders, spinal cord injury, traumatic brain injury, stroke
Research involving
Sponsors and support
Intervention
- Medical device
Outcome measures
Primary outcome
Handgrip strength
Secondary outcome
Maximal pinch strength, Handgrip endurance, Action Research Arm Test, Jebson-Taylor Hand Function Test, glove use data, Numeric Pain Rating Scale, Michigan Hand Outcomes Questionnaire- Dutch Language Version, Motor Activity Log, EuroQol-5D, Short-Form 36, Semi-instructed interview
Background summary
Different patient populations, such as orthopedic patients, spinal cord injured patients, traumatic brain injured patients and stroke patients 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. A wearable soft robotic glove was developed that can support the functional performance of the hand directly by assisting a person’s own function. In this way, people will probably use their affected hand more often during daily life, which can potentially result in an improved hand function after prolonged use of the robotic glove.
Study objective
The primary objective of the present study is to examine the therapeutic effect of the Carbon Hand system on handgrip strength in patients with hand function problems, after using the glove for six weeks at home. Secondary objectives are related to arm-/ hand function, amount of glove use and quality of life.
Study design
A multicenter uncontrolled intervention study will be conducted with three pre-assessments (T0, T1 and T2), a post-assessment (T3) and a follow-up assessment (T4).
Intervention
wearable soft-robotic glove (Carbonhand system)
Study burden and risks
The Carbon Hand may have a beneficial effect on hand function, by directly improving functional task performance. 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. The exact therapeutic benefit will be studied in the current research.
The risks for the participants are limited to a minimum. The Carbon Hand is a device that only facilitates handgrip based on voluntary, active initiation by the person him/herself. Furthermore, the Carbon Hand system is a so-called soft-robotic 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 this study are non-invasive and involve no risks for the participants."
Age
Inclusion criteria
1. Age between 18-80 years 2. People should be in a chronic and stable phase of disease 3. Receiving/having received treatment for limitations in performing ADL due to a decline in hand function (regardless of underlying disorder) at a rehabilitation center/department 4. People should have at least 10° of active extension of the wrist and fingers and 10 degrees of active flexion of the fingers 5. People should be able to make a pinch grip between thumb and middle or ring finger 6. People should be able to put on the Carbon Hand glove 7. Sufficient cognitive status to understand two-step instructions 8. Living at home 9. Provided written informed consent
Exclusion criteria
1. Severe sensory problems of the most-affected hand 2. Severe acute pain of the most-affected hand 3. Wounds on their hands that can give a problem when using the glove 4. Severe contractures limiting passive range of motion 5. Co-morbidities limiting functional use/performance of the arms/hands 6. Severe spasticity of the hand (≤2 points on Ashworth Scale) 7. Participation in other studies that can affect functional performance of the arm/hand 8. Receiving arm-/hand function therapy during the course of the study 9. Insufficient knowledge of the Dutch language to understand the purpose or methods of the study
Design
Recruitment
Medical products/devices used
IPD sharing statement
Postbus 2500
3430 EM Nieuwegein
088 320 8784
info@mec-u.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7561 |
| CCMO | NL68135.044.19 |
| OMON | NL-OMON55770 |