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Exploring and evaluating the hand and wrist associated modules and solution intended for the ReHyb system. Study 1B: Funktional electrical stimulation as assistance during activities of daily living

Exploring and evaluating the hand and wrist associated modules and solution intended for the ReHyb system. Study 1B: Funktional electrical stimulation as assistance during activities of daily living - pReHyb_1B

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025889
Enrollment
20
Registered
2021-09-29
Start date
2021-09-30
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paretic wrist or fingers due to an ischaemic or haemorrhagic stroke. I61 I63 I64

Interventions

Group 1: This study is conducted using a cross-over design, which means that each patient serves as his/her own control. Each study participant performs grasping tasks and clinical tests with the supp

Sponsors

Schön Klinik Bad Aibling
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Ischemic or hemorrhagic stroke; Cognitively able to follow instructions; Low level or no pain in wrist or fingers of the impaired limb (NRS < 4); Functional impairments in wrist or fingers (MRC <= 4); Level of spasticity in the affected limb (MAS <= 3); Able to sit in a chair for the duration of the session (about 1 hour)

Exclusion criteria

Exclusion criteria: Pregnancy; Severe psychiatric disorder; Active implantable devices (e.g. pace maker); metal implants within the stimulated area; severe epilepsy or frequent epileptic seizures in the past; Cancer; wounds in the application area of the electrodes; no sensitivity in the fingers or wrist; No motion resulting from FES

Design outcomes

Primary

MeasureTime frame
The primary outcome is the orthotic effect of functional electrical stimulation (FES). This is measured during three session in which 1) clinical taest and experimental grasping is performed with and without the support of FES, and 2) the time until signs of muscular fatigue are detected by data on grip force, hand motion and muscle activity during repetetive stimulation.

Secondary

MeasureTime frame
The secondary outcome is the patients' intrinsic motivation during the FES therapy. The intrinsic motivation is assessed after the session in which the patients is supported by FES and after the session in which there is no support by means ob a standardized questionnaire (Intrinsic Motivation Inventory).

Countries

Germany

Contacts

Public ContactCarmen Krewer

Schön Klinik Bad Aibling

CKrewer@schoen-klinik.de08061 903 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026