Exergame and Robotic Therapy Impact on Tenascin-C and Functional Outcome on Stroke Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHasanuddin University
About this trial
This clinical trial aims to compare the effectiveness of Robotic versus Exergame versus Standard therapy to improve hand function among post-stroke patients. The main questions it aims to answer are:
1, Effectiveness of interventions in functional outcome recovery across time 2. Effectiveness of interventions in affecting Tenascin-C level 3. Clinical outcome difference between all interventions
Participants will be allocated into three groups, either a robotic group, exergame group as the main interventions, and standard rehabilitation group as the active comparator. A serial follow-up will be conducted to assess the selected clinical outcome and differences in outcome
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients after ischemic or hemorrhagic stroke
stable hemodynamics and neurologic state.
Patients have never undergone treatment with any intervention
Able to watch television with or without glasses from a distance of 1 meter.
Disqualifiers
Patients with a history of seizures or epilepsy.
Patients with severe cognitive disorders that can interfere with research objectives (MMSE score <24).
Patients with field deficits or severe vision disorders.
The patient is unable to sit upright without help.
Trial design
Design model
Parallel
Treatments tested in this trial
Exergame
Procedure/SurgeryHand Training assisted with Virtual-Reality
Robotic
Procedure/SurgeryHand Training assisted with Robotic Syrebo
Conventional
Procedure/SurgeryHand Training with Physical Therapist
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: Standard Rehabilitation/ConventionalActive comparator 1 intervention
Group B: ExergameExperimental treatment 1 intervention
Group C: RoboticExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fugl-Meyer Assessment Upper Extremity (FMA-EU) Score
a motoric assessment with each score range from 0-2 with a total score range from 0-66. Higher score indicates better and free movement
Time frame
changes of FMA-UE score from pre-intervention to six weeks after intervention2
Nine Hole Peg Test Value
an assessment for finger dexterity and coordination where the time of the subject to accomplish task will be recorded. Average healthy adult male completed the NHPT in 19.0 seconds (SD 3.2) with the right hand, and in 20.6 seconds (SD 3.9) with the left hand. For healthy adult women, the NHPT was completed in 17.9 seconds (SD 2.8) and 19.6 seconds (SD 3.4) with the right and left hands, respectively.
Time frame
changes of NHPT values from pre-intervention to six weeks after intervention3
Handgrip Dynamometer value
The handgrip dynamometer measures hand strength, with a typical range of 0 to 100 kg (0 to 220 lb). For men, normal handgrip strength usually falls between 30-60 kg (66-132 lb), while for women it ranges from 20-40 kg (44-88 lb).
Time frame
changes of handgrip values from pre-intervention to six weeks after intervention4
Tenascin-C value
The normal range of Tenascin-C levels in healthy individuals typically falls between 50 to 200 ng/mL.
Time frame
changes of Tenascin-C value from pre-intervention to six weeks after interventionSponsors and contacts
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Source ClinicalTrials.gov