The primary objective of the present study is to examine the therapeutic effect of the Carbon Hand system on handgrip strength by patients with hand function problems, after using the glove for six weeks at home. Secondary objectives are related to…
ID
Source
Brief title
Condition
- Joint disorders
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Handgrip strength
Secondary outcome
Maximal pinch strength
Handgrip endurance
Action Research Arm Test
Jebsen-Taylor hand function test
Glove use data
Numeric Pain Rating Scale
Michigan Hand Outcomes Questionnaire- Dutch Language Version
Motor Activity Log
EuroQol 5-D
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 by 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
All participants will use the wearable robotic glove during ADL at home for a
period of six weeks. In addition, the participants receive an exercise book as
a guide to carry out daily (ADL) exercises with the glove. The participants are
recommended to use the robotic glove for 180 minutes a week.
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.
Roessinghsbleekweg 33B
Enschede 7522 AH
NL
Roessinghsbleekweg 33B
Enschede 7522 AH
NL
Listed location countries
Age
Inclusion criteria
1. Age between 18-90 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
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL68135.044.19 |
| Other | NTR: NL7651 |
| OMON | NL-OMON21637 |