Clinical trial NCT06184191: Combined Robotic Hand Rehabilitation and Conventional Rehabilitation for Post-stroke Rehabilitation
Official title: Comparison of the Effects of Combined and Individual Robotic Hand Rehabilitation and Conventional Rehabilitation on Daily Living Activity, Upper Extremity Functional Results and Hand Strength in Patients With Post-stroke Hemiplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiplegia
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2023-12-28
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: The investigators compared the effectiveness of individual and combined application of conventional rehabilitation and robotic hand rehabilitation in post-stroke hemiplegia. The study design is an An assessor-blinded, prospective randomized comparison study.

Methods: Patients were randomly assigned to one of three groups:

Group 1 (Robotic Hand Rehabilitation): The patients underwent robotic hand rehabilitation, Group 2 (Conventional Rehabilitation): The patients underwent conventional rehabilitation, Group 3 (Combined Rehabilitation): The patients underwent combined conventional and robotic hand rehabilitation at the same period.

Randomization was performed using the closed envelope method randomization sequence by an investigator who was not involved in patient care. The therapist opened the envelope 6 hours before the patient started treatment.

The investigators assessed Barthel index for activities of daily living (range, 0 - 100), Brunnstrom's hemiplegia recovery staging (range, stage 1 - stage 7), Fugl-Meyer upper extremity assessment scale (stage, 0 - 66), Abilhand stroke hand ability questionnaire assessment (range, 0 - 46), hand grip strength, and hand pinch strength at baseline and end of the rehabilitation (1-month).

Conclusions: There are many studies in the literature on the hand and upper extremity functions of Conventional Rehabilitation and Robotic Hand Rehabilitation in stroke. They revealed that both therapies had a positive effect on the results. There is no study on the effect of combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions. More successful hand functional results may be achieved by applying both rehabilitations together in stroke. The aim of our study is to compare the effects of early-term individually and concomitant Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions and hand strength in stroke. Our hypothesis is that the combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation together will provide better functional results of the hand and upper extremity.

Detailed description: Objective: Hemiplegia or hemiparesis is commonly seen after stroke.Upper limb function, particularly hand function, plays a crucial role in determining the quality of life and independence after stroke. Numerous studies have been conducted on rehabilitation to improve upper extremity function.There are many studies in the literature on the hand and upper extremity functions of Conventional Rehabilitation and Robotic Hand Rehabilitation in stroke. They revealed that both therapies had a positive effect on the results. There is no study on the effect of combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions. More successful hand functional results may be achieved by applying both rehabilitations together in stroke. The aim of our study is to compare the effects of early-term individually and concomitant Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions and hand strength in stroke. Our hypothesis is that the combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation together will provide better functional results of the hand and upper extremity.

Methods: 66 patients with post-stroke hemiplegia will include in our study. Grip strength was measured with a dynamometer (JamarR, PrestonTM, Jackson, MI) and pinch strength was measured with a specially designed instrument (Pinch gauge, B\&R EngineeringTM, Santa Fe Springs, CA). Measurements were made 3 times and the average value was taken. The patients were evaluated before rehabilitation and at the first month follow-up. The same therapist who was blind to the type of rehabilitation evaluated the patients before treatment and at the first month follow-up.

Conclusions: Combined Rehabilitation achieves results just as successful as Conventional Rehabilitation in terms of daily living activities, upper extremity functions, and hand functions. Additionally, it significantly outperformed Conventional Rehabilitation in improving hand functions, treating hand spasticity, and enhancing hand strength.

Eligibility criteria: Inclusion criteria:

* Diagnosed with cortical or subcortical stroke confirmed by radiological imaging
* Over 18 years old age
* Mini-Mental Scale (MMS) = 24-30
* Not having serious cognitive impairment (score ≥22)
* The rehabilitation of the patient was performed at the rehabilitation department of XXXXX Research and Training Hospital.

Exclusion criteria:

* Having a stroke lesion in other areas of the brain such as the cerebellum and brainstem
* Presence of joint or bone pathologies in the affected upper extremity
* Excessive spasticity in the elbow or wrist joints of the affected upper extremity (Modified Ashworth Scale score \>3)
* Having previously surgical treatment history on the affected extremity
* Having an additional neurological disease
* Not complying with treatment recommendations or inadequately applying.

Primary outcomes:
measure: Barthel index for activities of daily living
timeFrame: The patients were evaluated before rehabilitation and at the first month follow-up.
measure: Brunnstrom's hemiplegia recovery staging
timeFrame: The patients were evaluated before rehabilitation and at the first month follow-up.
measure: Fugl-Meyer upper extremity assessment scale
timeFrame: The patients were evaluated before rehabilitation and at the first month follow-up.
measure: ABILHAND stroke hand ability questionnaire assessment
timeFrame: The patients were evaluated before rehabilitation and at the first month follow-up.
measure: grip strength, and pinch strength
timeFrame: The patients were evaluated before rehabilitation and at the first month follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpaşa Training and Research Hospital
state: Gaziosmanpaşa
Study officials:
affiliation: Gaziosmanpasa Research and Education Hospital
name: BETÜL BAŞAR, Ass. Prof.
role: STUDY_CHAIR
References: