Robot-Assisted Rehabilitation in Individuals With Stroke

NCT ID: NCT05550311

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2023-10-15

Brief Summary

Stroke has a high rate of morbidity and mortality worldwide. This disease is the third leading cause of death after ischemic heart disease and cancer. Stroke is also the leading cause of disability in adults. It is known that stroke individuals have not only limb restriction, but also respiratory capacity and exercise capacity. It has been shown in the literature that upper extremity functions are directly related to respiratory capacity. Although it is known that upper extremity training has positive effects on respiratory capacity in stroke individuals, more studies are needed to examine the effects of upper extremity robot-assisted rehabilitation on respiratory capacity. The aim of this study is to examine the effects of upper extremity robot-assisted rehabilitation applied in addition to conventional treatment on respiratory parameters, dyspnea, and functional capacity.

Detailed Description

One of the most common complications in stroke patients is pulmonary aspiration and pneumonia, which are associated with respiratory functions being affected. Fluoroscopic examinations of stroke patients showed decreased movement in the diaphragm as well as in other muscles on the affected side. The combination of a decrease in respiratory parameters, weakness in respiratory muscles, and a decrease in diaphragmatic activity can cause dyspnea in individuals even that require minimal effort. The low level of physical activity is accompanied by a decrease in respiratory functions, and the participation of individuals in society decreases. The purpose of stroke rehabilitation is to reduce the complications caused by stroke and to increase the individual's psychological, social, physical, and professional level of independence and functionality to the highest level. Nowadays, stroke rehabilitation can be shaped by a variety of methods. In clinics, robotic rehabilitation is commonly used for stroke patients with the development of the technology. In the literature, studies show the effect of robotic rehabilitation on respiratory parameters, also robot-assisted walking training provides significant improvement in some respiratory parameters and increases aerobic capacity. The aim of this study is to evaluate the effects of upper extremity robot-assisted rehabilitation applied in addition to conventional treatment on respiratory parameters, dyspnea, and functional capacity in individuals with stroke.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robot group

In addition to conventional treatment, an upper extremity robot-assisted rehabilitation program will be applied for 45 minutes a day, two days a week.

Group Type: EXPERIMENTAL

Robot-assisted rehabilitation

Intervention Type: OTHER

In addition to conventional treatment, an upper extremity robot-assisted rehabilitation program. Range of motion exercises will display on the monitor as a game form. There are 4 games available on the computer (airplane game, rabbit shooting game, ball game, and shopping game) and these games can provide exercises for three joints (shoulder, elbow wrist). There are also 3 different levels of resistance apparatus for each joint. People with a full range of motion can do these exercises with resistance. Before starting the rehabilitation, which joint and which movement to do is determined. To the person; After explaining the desired movement and how to play the game shown on the monitor, the exercises are started. The exercises last 45 minutes, during which exercises are performed for the shoulder, elbow, and wrist.

Conventional rehabilitation

Intervention Type: OTHER

The conventional Rehabilitation Program consists of; range of motion exercises, strengthening exercises, stretching exercises, balance, and walking exercises and Bobath based neurophysiological approaches.

Control Group

Participants in this group will be included in a conventional rehabilitation program

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type: OTHER

The conventional Rehabilitation Program consists of; range of motion exercises, strengthening exercises, stretching exercises, balance, and walking exercises and Bobath based neurophysiological approaches.

Interventions

Robot-assisted rehabilitation

In addition to conventional treatment, an upper extremity robot-assisted rehabilitation program. Range of motion exercises will display on the monitor as a game form. There are 4 games available on the computer (airplane game, rabbit shooting game, ball game, and shopping game) and these games can provide exercises for three joints (shoulder, elbow wrist). There are also 3 different levels of resistance apparatus for each joint. People with a full range of motion can do these exercises with resistance. Before starting the rehabilitation, which joint and which movement to do is determined. To the person; After explaining the desired movement and how to play the game shown on the monitor, the exercises are started. The exercises last 45 minutes, during which exercises are performed for the shoulder, elbow, and wrist.

Intervention Type: OTHER

Conventional rehabilitation

The conventional Rehabilitation Program consists of; range of motion exercises, strengthening exercises, stretching exercises, balance, and walking exercises and Bobath based neurophysiological approaches.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Between the ages of 18-65,
• Diagnosed with hemorrhagic or ischemic stroke,
• Having a stroke history of at least 3 months,
• Being 16 and above according to the Mini-Mental State Test,
• Three and above according to the Brunnstrom stage,
• Individuals not included in another rehabilitation program will be included.

Exclusion Criteria

• Chronic cardiac or pulmonary diseases such as COPD, asthma, interstitial lung disease, and heart failure,
• Using tobacco and tobacco products,
• Severe spasticity to prevent robotic rehabilitation (on Modified Ashworth Scale,
• With skin ulcers,
• Non-union or unstable fracture status,
• Individuals with pressure sores will not be included.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biruni University

OTHER

Sponsor Role: lead

Responsible Party

Buket AKINCI

Assoc.Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Buket AKINCI, Assoc.Prof.

Role: STUDY_CHAIR

Biruni University

Locations

Biruni University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Okumus B, Akinci B, Aytutuldu GK, Baran MS. Impact of upper extremity robotic rehabilitation on respiratory parameters, functional capacity and dyspnea in patients with stroke: a randomized controlled study. Neurol Sci. 2025 Mar;46(3):1257-1266. doi: 10.1007/s10072-024-07868-z. Epub 2024 Nov 11.

Reference Type: DERIVED

PMID: 39527236 (View on PubMed)

Other Identifiers

65-22-10

Identifier Type: -

Identifier Source: org_study_id