Exploring and evaluating the hand and wrist associated modules and solution intended for the ReHyb system. Study 2A: Usability and feasibility of the combination of serious gaming and functional electrical stimulatio

Not Applicable

• Conditions: paresis in wrist or fingers due to ischemic or hemorrhagic stroke; I61; I63; I64; Intracerebral haemorrhage; Cerebral infarction; Stroke, not specified as haemorrhage or infarction

• Registration Number: DRKS00025761
• Lead Sponsor: Schön Klinik Bad Aibling

Brief Summary

The combination of SG with ccFES is feasible and well-accepted among patients after stroke. It seems that the additional use of ccFES may be more beneficial for severely impaired patients as it enables the execution of the serious game. These findings provide valuable implications for the development of rehabilitation systems by combining different therapeutic interventions to increase patients’ benefit and proposes system modifications for home use.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-06
• Study Completion: 2022-12-15
• Results First Posted: 2023-05-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

ischemic or hemorrhagic stroke
- age>=18
- cognitively able to follow instructions
- low level or no pain in wrist or fingers (NRS<4)
- functional impairment 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 disorders, active implantable devices, metal implants within the stimulated area, severe epilepsy or frequent 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
usability and feasibility of the combination of FES and serious gaming, evaluated using a questionnaire that includes the IMI (intrinsic motivation inventory), NASA-TLX (Nasa Task Load Index) and the SUS (System Usability Scale)

Secondary Outcome Measures

Name	Time	Method
training duration, technical and user documentation