Clinical trial NCT06692829: Robot-Assisted Therapy in Chronic Stroke Patients
Official title: Investigation of the Effects of Robot-Assisted Therapy Added to Conventional Therapy on Hand Functions, Spasticity and Quality of Life in Patients With Chronic Stroke: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Hemiplegia
Keywords: stroke
hemiplegia
robotic rehabilitation
hand function
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Considering the paucity of studies on robotic hand therapy, larger-scale and long-term follow-up studies are needed. The aim in this study is to demonstrate the effectiveness of robot-assisted hand therapy in patients with chronic stroke and to compare this effectiveness in patients with different Brunnstrom stages.

Detailed description: Stroke is one of the leading causes of disability worldwide. Although mortality is decreasing, the number of people living with the effects of stroke has increased due to the increasing and aging population. It has been observed that 26% of patients have decreased basic daily living activities and 50% have decreased mobility after stroke.

Effective therapy in stroke rehabilitation should include repetitive, functional and task-specific exercises performed with high intensity and duration. In this context, in addition to traditional treatments, many new treatment approaches have come to the fore in recent years. Robot-assisted treatment (RAT) is one of these new treatment approaches. The use of robotic technology in rehabilitation has gained importance especially in the last 15 years and developments in this regard continue to increase. RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications.

This technology-based treatment increases the efficiency of rehabilitation care with its features of intensity, interaction, flexibility and adaptability to the patient performance and needs. It has no significant side effects and is well tolerated by patients. In the literature on robot-assisted treatment, different robotic devices have been used in various studies and different treatment protocols have been applied. This treatment has been reported to provide significantly greater improvement in function compared to conventional usual care. Studies in the literature on RAT demonstrate the feasibility of using these technologies in large patient groups.

The most common and devastating consequence of post-stroke disability is functional disability in the upper extremity. The functional prognosis of the lower extremity is generally better than the upper extremity after stroke. 20-30% of patients can walk normally, and 75% can reach some stage of ambulation. However, only 5% of patients return to normal upper extremity function, while 23-43% show inadequate functional recovery. Therefore, upper extremity rehabilitation requires more time and effort than lower extremity rehabilitation.

Bertani et al. In their published meta-analysis, they stated that robot-assisted rehabilitation is more effective in improving upper extremity motor function, especially in patients with chronic stroke, compared to conventional therapy. Amadeo (Tyromotion, Graz, Austria), an end-effector robotic rehabilitation device designed for hand rehabilitation, has shown feasibility and preliminary efficacy for stroke in the subacute phase. A randomized controlled trial with 17 patients compared conventional occupational therapy with Amadeo robotic therapy and after forty sessions, both groups showed significant improvement, but robotic intervention caused a greater improvement in hand function as measured by Fugl-Meyer and Motricity Index. Robotic hand therapy has started to take its place in routine rehabilitation protocols today. Considering the scarcity of studies on robotic hand therapy, it has been seen that larger-scale and long-term follow-up studies are needed. The aim in this study is to demonstrate the effectiveness of robot-assisted hand therapy in patients with chronic stroke and to compare this effectiveness in patients with different Brunnstrom stages.

Eligibility criteria: Inclusion Criteria:

* who were 3 months post-CVA
* whose health status was suitable for rehabilitation
* who could understand commands with a mini mental test score of 15 and above.

Exclusion Criteria:

* Patients with persistent upper extremity pain on the hemiplegic side (VAS\&gt;40)
* severe spasticity in the hand (MAS≥3)
* contracture in the hand
* fracture or surgery on the hemiplegic side within the last 6 months
* botulinum toxin injection into the upper extremity within the last 6 months
* skin ulcers
* brainstem or cerebellar lesions
* neglect or apraxia
* severe visual defects
* severe depression

Primary outcomes:
measure: Brunnstrom Staging
timeFrame: Before treatment (T0) At the end of the treatment (10. week) (T1)
measure: Modified Ashworth Scale
timeFrame: Before treatment (T0) At the end of the treatment (10. week) (T1)
measure: Fugl Meyer Upper Extremity Assessment Questionnaire
timeFrame: Before treatment (T0) At the end of the treatment (10. week) (T1)
measure: ABILHAND Stroke Hand Function Questionnaire
timeFrame: Before treatment (T0) At the end of the treatment (10. week) (T1)
Secondary outcomes:
measure: Mini Mental Test
timeFrame: Before treatment (T0) At the end of the treatment (10. week) (T1)
measure: Stroke Impact Survey
timeFrame: Before treatment (T0) At the end of the treatment (10. week) (T1)
measure: Stroke Specific Quality of Life Scale (SSQOL)
timeFrame: Before treatment (T0) At the end of the treatment (10. week) (T1)
Other outcomes:
Locations:
Study officials:
References: