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Can the predefined on-body sensing system be used for the qualification of the arm and balance function of patients after stroke.

Objective qualification of balance control and arm function in stroke subjects using on-body sensing: Evaluation of principles in a simulated ambulatory setting.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23377
Enrollment
20
Registered
2012-09-21
Start date
2013-01-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Stroke Beroerte

Interventions

For all subjects the experiment will be the same. No randomization will be aplied, no control group will be included. During the single measurement session, the sensors will be attached to the body.

Sponsors

Primary sponsor - This project is part of the Seventh Framework Programme (FP7) funded by the European Union.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age above 35 years; 2. Age below 75 years; 3. At least 6 months post-stroke; 4. Had only one unilateral ischaemic or haemorrhagic hemiparetic stroke; 5. Ability to lift the arm (at least partly) against gravity, without suffering; 6. Ability to walk (possibly with walking aid) for over 10 meters, without suffering; 7. Ability to walk without specific footwear (ability to walk on sandals); 8. No pain or other condition interfering with the mobility and/or strength of the arm; 9. Ability to understand and perform instructions and questionnaires; 10. Provide written informed consent (IC).

Exclusion criteria

Exclusion criteria: 1. Medical history of more than one stroke events; 2. Complicating medical history such as cardiac, pulmonary, or orthopaedic disorders that could affect performance of the included measurements; 3. Severely impaired sensation; 4. Suffering from comprehensive aphasia.

Design outcomes

Primary

MeasureTime frame
Using on-body sensing systems, inertial sensors, force sensors and EMG-sensors; movement, forces and muscle activity will be measured. Measured data will be analyzed and the main study parameters will be calculated. These parameters are subdivided into three groups: temporal (number of movements), kinetic (centre of pressure, underneath the foot) and kinematic (step width, step size, range of motion). Each group contains several parameters of which a combination of parameters and/or (a)symmetry of parameters will be used to qualify motor function.

Secondary

MeasureTime frame
Secondary parameters are the clinical tests (Timed Up and Go Test, Berg Balance Scale, Fugl Meyer, Stroke Upper Limb Capacity Scale, Barthel index) which are already used in clinical practice to assess balance, reaching tasks and daily-life activity. The results of these tests will be correlated to the results of primary study parameters by calculating the regression coefficients and intraclass correlation between the clinical tests and the parameters as described in the main parameters.

Contacts

Public ContactF.B. Meulen, van

University of Twente Biomedical Signals and Systems Zuid-Horst ZH 229 P.O. 217

f.b.vanmeulen@utwente.nl+31 (0)53 4892740

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)