Robot-Assisted Rehabilitation in Individuals With Stroke

NCT05550311 | Completed

• 1 other identifier: 65-22-10
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

robot-assisted training; respiratory parameters

Outcome Measures

Primary Outcomes (4)

• Forced expiratory volume 1. second (FEV1)/ Forced vital capacity (FVC) ratio

  Spirometric evaluation will be performed to determine the FEV1/FVC value of the participants.

  Change from Baseline Forced expiratory volume 1. second (FEV1)/ Forced vital capacity (FVC) ratio at 6 weeks

• Maximal inspiratory pressure

  Mouth pressure will be assessed to document inspiratory muscle strength

  Change from Baseline Maximal inspiratory pressure at 6 weeks

• Maximal expiratory pressure

  Mouth pressure will be assessed to document expiratory muscle strength

  Change from Baseline Maximal expiratory pressure at 6 weeks

• Peak Expiratory Flow Rate

  Spirometric assessment will be performed to determine participants' peak expiratory flow rate.

  Change from Baseline Peak Expiratory Flow Rate at 6 weeks

Secondary Outcomes (5)

• Peak cough flow

  Change from Baseline Peak cough flow at 6 weeks

• 6 Minutes Walking Test

  Change from Baseline 6 Minutes Walking Test at 6 weeks

• Time Up and Go Test

  Change from Baseline Time Up and Go Test at 6 weeks

• Dyspnea-12 Scale

  Change from Baseline Dyspnea-12 Scale at 6 weeks

• Satisfaction survey

  At 6 weeks

Study Arms (2)

Robot group

EXPERIMENTAL

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

Other: Robot-assisted rehabilitation; Other: Conventional rehabilitation

Control Group

ACTIVE COMPARATOR

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

Other: Conventional rehabilitation

Interventions

Robot-assisted rehabilitation 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.

Robot group

Conventional rehabilitation 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; Robot group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39527236 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Buket AKINCI, Assoc.Prof.

  Biruni University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will be blind to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 22, 2022
• Study Start: November 15, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 15, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

TU (1)