Effect of Robotic Therapy on Upper Extremity With Stroke

Not Applicable

Completed

• Conditions: the Effect of Virtual Reality on Stroke Rehabilitation
• Interventions: Other: conventional therapy; Other: robotic exercise therapy

• Registration Number: NCT05815823
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-01
• Study First Submitted: 2023-03-22
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-04
• Last Update Submitted: 2023-04-04
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional therapy	conventional therapy	20 sessions of conventional therapy was applied for 5 days a week for 4 weeks, 1 hour a day
robot-assisted therapy	robotic exercise therapy	20 sessions of upper extremity robot-assisted therapy was applied for 4 weeks, 5 days a week, 30 minutes a day.
robot-assisted therapy	conventional therapy	20 sessions of upper extremity robot-assisted therapy was applied for 4 weeks, 5 days a week, 30 minutes a day.

Primary Outcome Measures

Name	Time	Method
FMA-UE scale	after treatment (1 month)	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.