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

Not Applicable

• Conditions: Paretic wrist or fingers due to an ischaemic or haemorrhagic stroke.; I61; I63; I64; Intracerebral haemorrhage; Cerebral infarction; Stroke, not specified as haemorrhage or infarction

• Registration Number: DRKS00025889
• Lead Sponsor: Schön Klinik Bad Aibling

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-29
• Study Completion: 2022-04-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).