Clinical trial NCT05559385: Is Robot-Assisted Therapy Effective for the Upper Extremity Following a Stroke
Official title: Is Robot-Assisted System Effective for the Maximization of Upper Extremity Motor Recovery in Intensive Body Rehabilitation Following a Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Robotic Rehabilitation
Conventional Rehabilitation
Intensıve Trunk Rehabilitation
Motor Function
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Controlled (One group received Robotic Rehabilitation, other group received conventional rehabilitation)
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Upper Extremity Assessment:
timeFrame: At the baseline
measure: Fugl-Meyer Upper Extremity Assessment:
timeFrame: At the end of the 6th week
Secondary outcomes:
measure: Demographic Data Form
timeFrame: At the baseline
measure: - Wolf Motor Function Test:
timeFrame: At the baseline
measure: - Wolf Motor Function Test:
timeFrame: At the end of the 6th week
measure: Trunk Impairment Scale
timeFrame: At the baseline
measure: Trunk Impairment Scale
timeFrame: At the end of the 6th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: Aysel Yildiz Ozer, PhD
role: STUDY_DIRECTOR
affiliation: Gelişim University
name: Adem Aktürk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bağcılar Education and Research Hospital
name: Elif Korkut, PhD
role: PRINCIPAL_INVESTIGATOR
References: