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CompletedNCT05815823Updated Apr 18, 2023

Effect of Robotic Therapy on Upper Extremity With Stroke

An interventional study of robotic exercise therapy and conventional therapy in the Effect of Virtual Reality on Stroke Rehabilitation, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Completed. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 years 2 months after the study started (first participant enrolled Jan 2015, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
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Study summary

The purpose of this study is to determine how adding virtual reality assisted robotic treatment to traditional rehabilitation affects stroke patients' pain levels, functional status, and daily living activities.After conventional and robotic therapy Each patient was evaluated The Barthel Index (BI), the Fugl Meyer Assessment Upper Extremity (FMA-UE), and the Visual Analogue Scale (VAS) were used to assess the patients' pain, daily living activities, and upper extremity motor function.

Read the detailed description

The purpose of this study is to determine how adding virtual reality assisted robotic treatment to traditional rehabilitation affects stroke patients' pain levels, functional status, and daily living activities.

Materials and Methods: The study included 40 stroke patients. Two groups of patients were created. Group I also underwent 20 sessions of upper extremity robot-assisted therapy for 4 weeks, 5 days a week, for 30 minutes per session, in addition to receiving conventional therapy (5 days a week for 4 weeks, 1 hour each day). Group II only got traditional therapy. Each patient was assessed both before and after the procedure.

The Barthel Index (BI), the Fugl Meyer Assessment Upper Extremity (FMA-UE), and the Visual Analogue Scale (VAS) were used to assess the patients' pain, daily living activities, and upper extremity motor function.

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Conditions studied

  • the Effect of Virtual Reality on Stroke Rehabilitation

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Keywords

  • stroke
  • upper extremity
  • robot-assisted therapy
  • armeo
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital is the lead sponsor of 119 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Ischemic or hemorhagic hemiplegia
  • Brunnstrom upper extremity motor stage ≥3
  • At least 3 months have passed
  • Modified Ashworth Score ≤2
  • 18-85 year old patients with diagnosis of stroke

Exclusion criteria

Exclusion Criteria:

  • Aphasia
  • Cognitive impairment
  • mini mental test \<24
  • deformity and / or contracture in the upper extremity
  • Patients diagnosed with KBAS
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    conventional therapy

    20 sessions of conventional therapy was applied for 5 days a week for 4 weeks, 1 hour a day

    Other: conventional therapy

  • Experimental
    robot-assisted therapy

    20 sessions of upper extremity robot-assisted therapy was applied for 4 weeks, 5 days a week, 30 minutes a day.

    Other: robotic exercise therapy · Other: conventional therapy

Interventions

  • Otherrobotic exercise therapy

    Functional exercise programs such as collecting rain in a glass, grating vegetables, goalkeeper, cleaning the stove, watering flowers, wiping windows, catching fish, and exploring landscapes were applied by robotic games to the patients

    Also known as: robotic exercise

  • Otherconventional therapy

    streching, range of motion, strengthening, balance and walking exercise

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What researchers measure

Primary outcomes

  1. FMA-UE scale

    FMA-UE evaluates the hemiparetic arm's mobility, including reflexes, the presence of synergies, and each of the upper limb's independent motions, including grasp. The dysmetria, coordination, and velocity of the patient are also evaluated using items on this scale. It is intended to assess muscle strength, reflex actions, and movement control in the upper extremity following a stroke. It has 33 elements and accepts values ranging from 0 to 2. Scores under 31 suggest a weak upper extremity, scores between 32 and 47 show a restricted upper extremity, scores between 48 and 52 indicate a noteworthy upper extremity, and scores between 53 and 66 indicate a full upper extremity.

    Time frame: baseline

  2. FMA-UE scale

    FMA-UE evaluates the hemiparetic arm's mobility, including reflexes, the presence of synergies, and each of the upper limb's independent motions, including grasp. The dysmetria, coordination, and velocity of the patient are also evaluated using items on this scale. It is intended to assess muscle strength, reflex actions, and movement control in the upper extremity following a stroke. It has 33 elements and accepts values ranging from 0 to 2. Scores under 31 suggest a weak upper extremity, scores between 32 and 47 show a restricted upper extremity, scores between 48 and 52 indicate a noteworthy upper extremity, and scores between 53 and 66 indicate a full upper extremity.

    Time frame: after treatment (1 month)

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05815823
Lead sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Responsible party
Canan Avcı (Specialist of physical medicine and rehabilitation, Istanbul Physical Medicine Rehabilitation Training and Research Hospital) — Principal investigator
First posted
Apr 18, 2023
Start date
Jan 1, 2015
Primary completion
Jan 1, 2017
Completion
Jan 1, 2017
Last update
Apr 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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