Exergame and Robotic Therapy Impact on Tenascin-C and Functional Outcome on Stroke Patients

NCT06563206 | Recruiting DMC

• 1 other identifier: 0208242322
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Stroke; Paralysis Arm

Keywords

Robotic Rehabilitation; Video-assisted Rehabilitation; Post-Stroke; Functional Outcome; Tenascin-C

Outcome Measures

Primary Outcomes (4)

• 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

  changes of FMA-UE score from pre-intervention to six weeks after intervention

• 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.

  changes of NHPT values from pre-intervention to six weeks after intervention

• 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).

  changes of handgrip values from pre-intervention to six weeks after intervention

• Tenascin-C value

  The normal range of Tenascin-C levels in healthy individuals typically falls between 50 to 200 ng/mL.

  changes of Tenascin-C value from pre-intervention to six weeks after intervention

Study Arms (3)

Standard Rehabilitation/Conventional

ACTIVE COMPARATOR

The conventional exercise therapy group will be given diathermic, electricity modality, hydrotherapy, and therapeutic exercises in the form of muscle stretching, strengthening exercises, transfer exercises, walking exercises, and hand function exercises for 3 times a week within 6 weeks.

Procedure: Conventional

Exergame

EXPERIMENTAL

Conventional therapy coupled with virtual reality Exergame exercises on the hands for 3 times a week a time 6 weeks

Procedure: Exergame

Robotic

EXPERIMENTAL

conventional therapy coupled with robotic therapy exercises on the hands for 3 times a week a time of 6 weeks

Procedure: Robotic

Interventions

Exergame PROCEDURE

Hand Training assisted with Virtual-Reality

Exergame

Robotic PROCEDURE

Hand Training assisted with Robotic Syrebo

Robotic

Conventional PROCEDURE

Hand Training with Physical Therapist

Standard Rehabilitation/Conventional

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients can understand informed consent to participate in research

You may not qualify if:

• 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.
• Patients with significant pain in the affected upper limb.
• Patients with significant sensory decreases in the upper limb that are affected
• Patients with other medical conditions (musculoskeletal, neuromuscular, cardio respiration) are uncontrolled and are at risk of disrupting the ability to exercise.
• Dropout Criteria
• Patients who were declared dead
• Refusing to continue the training session or less \< 50% of all sessions.
• Experiencing hemodynamic and neurological disorders during the training program process.
• Experiencing cybersickness twice in successive training sessions

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (2)

Hasanuddin University, Faculty of Medicine

Makassar, South Sulawesi, 90245, Indonesia

RECRUITING

Wahidin Sudirohusodo General Hospital

Makassar, South Sulawesi, 90245, Indonesia

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Exergaming; Robotics; Congresses as Topic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Automation; Technology; Technology, Industry, and Agriculture; Organizations; Health Care Economics and Organizations

Study Officials

• Rumaisah Hasan, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Auliyah Fadly, MD

CONTACT

+6281234328649; muh.auliyah.fadly@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator will be masked from the allocation as well as outcome assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This study will be conducted using parallel design of three different rehabilitation approach with repeated measurements of outcomes, before and after intervention.

Study Record Dates

• First Submitted: August 17, 2024
• First Posted: August 20, 2024
• Study Start: October 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)