Stroke
Conditions
Keywords
Upper extremity, Rehabilitation, Robot assisted therapy, Robotics, Devices, Orthosis
Brief summary
The purpose of this study is to investigate the usability of a new upper limb robot assisted therapy device in stroke patients.
Detailed description
The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT. In this pilot study, the usability of a new upper arm RAT device for upper arm rehabilitation in stroke patients is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow, which is combined with a stabilizing shoulder brace and a bionic glove.
Interventions
DEVICETest upper limb robot assisted therapy device
During 1 session of 1/2 hour.
During 2 to 5 sessions of 1/2 hour.
Sponsors
Ortho-Medico
Thomas More Kempen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Phase 1: Healthy persons Phase 2: Stroke patients
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy subjects: Inclusion criteria: * Persons between 18 and 85 years old that can perform all sorts of daily activities with their upper limbs * Ability to sit on a chair with adequate trunk stability * Ability to follow verbal instructions * Ability to communicate verbally with the researchers
Exclusion criteria
* Ever had a fracture in the upper limbs * Ever had a surgery in the upper limbs * Pain in the upper limbs obstructing the execution of daily activities with the upper limbs * Physical trauma in the two months preceding the research * Mental problems that make the execution of daily activities unreliable * (Chronic) subluxation of the shoulder joint * Secundary soft tissue problems which may complicate the research or make it impossible (e.g. shoulder impingement, musculoskeletal problems, sensory deficits) * Pregnancy * Pacemaker * Known allergies for one of the components of the ARTHE rehabilitation tool 2. Stroke patients: Inclusion criteria: * Stroke patients, more than three months after onset * Aged between 18 and 85 years * None to moderate spasticity in the hemiplegic arm (Modified Ashworth Scale: 0-2) * Detectable voluntary muscle activity at elbow flexion and elbow extension of the hemiplegic arm (Medical research council score: 1-5) * Ability to sit on a chair with adequate trunk stability * Ability to follow verbal instructions * Ability to communicate verbally with the researchers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigate user experience by a self-composed questionnaire. | Up to 30 minutes at the last session | Investigate user experience by a self-composed questionnaire with theorems where upon users have to score. Possible scores range from 1 (totally disagree) to 4 (totally agree). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure the rate of perceived exertion by the Borg scale. | Up to 5 minutes at the last session | Measure the rate of perceived exertion by the Borg scale. The Borg scale is a way of measuring physical activity intensity level. Possible scores range from 0 (no fatigue at all) to 10 (worst imaginable fatigue). |
| Investigate whether wearing the device improves functionality by the Action Research Arm Test (ARAT). | Up to 5 weeks (at week 1, week 2 and week 5) | The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia. |
Countries
Belgium
Contacts
Primary ContactLieven De Maesschalck
Backup ContactRomy Sels
Outcome results
None listed