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NCT Number: NCT06184191

Combined Robotic Hand Rehabilitation and Conventional Rehabilitation for Post-stroke Rehabilitation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpaşa Training and Research Hospital

Istanbul, Gaziosmanpaşa, 34255, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic hand rehabilitation

Other

Robotic hand rehabilitation devices are the most advanced, effective and user-friendly combination of technology to support motor rehabilitation of the upper limb and neurocognitive recovery. Serving patients, doctors, therapists through therapies and protocols that accompany all stages of the rehabilitation process, the devices promote the functional recovery of patients and their reintegration into daily life.

Other names: Conventional rehabilitation, Combined conventional and robotic hand rehabilitation

Primary outcomes

  1. Barthel index for activities of daily living

    Time frame: The patients were evaluated before rehabilitation and at the first month follow-up.

    Barthel index was used to evaluate the daily living activities of the patients. Total score is between 0 - 100. 0 - 20 completely dependent, 21 - 61 highly dependent, 62 - 90 moderately dependent, 91 - 99 slightly dependent, 100 completely independent.

  2. Brunnstrom's hemiplegia recovery staging

    Time frame: The patients were evaluated before rehabilitation and at the first month follow-up.

    It was used to evaluate hemiplegia recovery upper extremity. It has 7 stages. Stage 1: There is no movement in the held arm. It is flask. Stage 7: Normal motor function is regained.

  3. Fugl-Meyer upper extremity assessment scale

    Time frame: The patients were evaluated before rehabilitation and at the first month follow-up.

    It was used to evaluate upper extremity function. Total score is between 0 - 66.

  4. ABILHAND stroke hand ability questionnaire assessment

    Time frame: The patients were evaluated before rehabilitation and at the first month follow-up.

    It was used to evaluate stroke hand function. Total score is between 0 - 46.

  5. grip strength, and pinch strength

    Time frame: The patients were evaluated before rehabilitation and at the first month follow-up.

    It was used to evaluate hand strength.

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 28, 2023
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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