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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06184191
• Other study ID #: GaziosmanpasaTraining&Research
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: December 2023
• Source: Gaziosmanpasa Training and Research Hospital, University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Other:
• Robotic hand rehabilitation
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.

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa Training and Research Hospital	Istanbul	Gaziosmanpasa

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Training and Research Hospital, University of Health Sciences

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barthel index for activities of daily living	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.	The patients were evaluated before rehabilitation and at the first month follow-up.
Primary	Brunnstrom's hemiplegia recovery staging	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.	The patients were evaluated before rehabilitation and at the first month follow-up.
Primary	Fugl-Meyer upper extremity assessment scale	It was used to evaluate upper extremity function. Total score is between 0 - 66.	The patients were evaluated before rehabilitation and at the first month follow-up.
Primary	ABILHAND stroke hand ability questionnaire assessment	It was used to evaluate stroke hand function. Total score is between 0 - 46.	The patients were evaluated before rehabilitation and at the first month follow-up.
Primary	grip strength, and pinch strength	It was used to evaluate hand strength.	The patients were evaluated before rehabilitation and at the first month follow-up.