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Is Robot-Assisted Therapy Effective for the Upper Extremity Following a Stroke

Is Robot-Assisted System Effective for the Maximization of Upper Extremity Motor Recovery in Intensive Body Rehabilitation Following a Stroke

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05559385
Enrollment
41
Registered
2022-09-29
Start date
2022-01-02
Completion date
2022-08-05
Last updated
2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Robotic Rehabilitation, Conventional Rehabilitation, Intensıve Trunk Rehabilitation, Motor Function

Brief summary

The aim of this study was to investigate the effects on upper-limb motor function of the addition of robotic rehabilitation (RR) and conventional rehabilitation (CR) treatments to intensive trunk rehabilitation (ITR). A total of 41 subacute stroke patients were randomly allocated to two groups: RR and CR. Both groups received the same ITR procedure (6x5x60 weeks/days/minutes). Following ITR, a robot-assisted rehabilitation program of 60 minutes, five days a week, for six weeks, was applied to the RR group, and an individualized upper extremity rehabilitation program to the CR group. Evaluations were made at baseline and after six weeks using the Trunk Impairment Scale (TIS), Fugl-Meyer Upper Extremity Motor Evaluation Scale (FMA-UE), and Wolf Motor Function Test (WMFT).

Detailed description

Assessments: \- Demographic Data Form: The researchers created a form to include the information on age, gender, stroke onset date, lesion type, affected side, and dominant extremity. \- Fugl-Meyer Upper Extremity Assessment: This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients (18). It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition. The affected upper extremities are assessed with the subject in a seated position. \- Wolf Motor Function Test: This test was created to evaluate the motor ability of the upper extremity (19). The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The total score is used for the functional ability of the patients. The two items of muscle strength evaluation were not used in this study. \- Trunk Impairment Scale: This scale evaluates static and dynamic sitting balance and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance. The test-retest and inter-rater reliability coefficients of the scale have been shown to be 0.85-0.99 (21).

Interventions

DEVICERobot-Assissted Therapy

Houston Bionics ExoRehab X brand/model device was used for improving the upper extremity in subacute stroke.

PROCEDUREConventional Rehabilitation

It is an upper extremity rehabilitation program prepared in line with individual needs.

Sponsors

Emresenocak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A Randomized Controlled (One group received Robotic Rehabilitation, other group received conventional rehabilitation)

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Age 40-85 years and having had a stroke in the last six months, * Mini-Mental State Assessment score \>20, * Able to sit safely, * No neglect issue, * Fugl-Meyer Upper Extremity Assessment score \<58.

Exclusion criteria

* Modified Ashworth Scale \>2, * Severe reduction in visual acuity, * Participation in another rehabilitation program, * Subluxation or pain in the shoulder region.

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Upper Extremity Assessment:At the baselineThis disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients. It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition.

Secondary

MeasureTime frameDescription
Demographic Data FormAt the baselineDemographic Characteristics
- Wolf Motor Function Test:At the baselineThis test was created to evaluate the motor ability of the upper extremity. The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The two items of muscle strength evaluation were not used in this study. A high score indicates fine motor ability.
Trunk Impairment ScaleAt the baselineThis scale evaluates static and dynamic sitting balance, and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026