Effects of Armeo Power Robot Therapy on Upper Limb Recovery in Hemiplegic Stroke Patients

Not Applicable

Completed

• Conditions: Rehabilitation of Upper Limb Motor Function in Hemiplegia Due to Supratentorial Cerebral Infarction Using Armeo Power Robot

• Registration Number: NCT06708065
• Lead Sponsor: Hanoi Medical University

Brief Summary

This study investigates the effectiveness of combining Armeo Power robotic therapy with conventional rehabilitation techniques to improve upper limb motor function in patients with hemiplegia caused by supratentorial cerebral infarction (a type of stroke). The study aims to evaluate how robotic-assisted therapy can enhance recovery by measuring motor function improvements over three weeks of treatment. Participants will undergo standard physical and occupational therapy alongside Armeo Power training, with results compared to those receiving only standard rehabilitation. The findings aim to provide valuable insights into advanced therapeutic options for stroke rehabilitation.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-08-30
• Status Verified: 2024-11
• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-11-24
• Last Update Submitted: 2024-11-24
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of upper limb motor function improvement according to 3 scales: FMA-UE, ARAT and HMS in 2 study groups.	There are 2 time points for evaluating the research subjects in both groups: Time 1: before intervention Time 2: After the end of 15 intervention sessions (about 3 weeks)	The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is a standardized clinical test used to evaluate the recovery of upper limb motor function in patients after a stroke. This scale is widely recognized for its reliability and sensitivity in assessing motor recovery during rehabilitation. The test comprises 8 assessment domains with a total of 33 items, and the maximum score achievable is 66 points. Based on the total score, recovery is categorized into four levels: good (56-66 points), indicating near-complete recovery of motor function; fair (42-54 points), reflecting moderate recovery; average (22-40 points), representing limited recovery with partial functionality; and poor (0-20 points), signifying severe motor impairment

Secondary Outcome Measures

Name	Time	Method
Action Research Arm Test	The Action Research Arm Test (ARAT) can be administered at two time points: baseline (initial assessment) and after 3 weeks to evaluate changes in upper limb function over the course of rehabilitation.	The Action Research Arm Test (ARAT) is a clinical scale designed to assess upper limb function, encompassing both gross motor skills and fine motor skills of the hand and fingers. The test evaluates four primary categories of movement: grasping large objects, grasping medium-sized objects, pinching small objects, and gross arm movements. The maximum score for the ARAT is 57 points, with recovery outcomes classified into three levels: good recovery (57 points), indicating full restoration of function; moderate recovery (10-56 points), reflecting partial functional ability; and poor recovery (\<10 points), signifying severe impairment.
Hand Movement scale	can be administered at two time points: baseline (initial assessment) and after 3 weeks to evaluate changes in upper limb function over the course of rehabilitation.	The Hand Movement Scale (HMS) is a clinical tool used to evaluate the motor function of the hand and fingers. The scale is divided into six levels, with scores ranging from 1 to 6, corresponding to increasing levels of movement and dexterity. The scoring reflects progression from no movement (1 point) to the highest level, which is the ability to oppose the thumb (digit I) to the other fingers (6 points). The HMS results are categorized into two levels: poor function (1-3 points) and good function (4-6 points)

Trial Locations

Locations (1)

108 Military Central Hospital; 🇻🇳 Ha Noi, Vietnam