Robot-Assisted Rehabilitation in Individuals With Stroke

Sponsor
Biruni University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05550311
Collaborator
(none)
34
1
2
4.5
7.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Robot-assisted rehabilitation
  • Other: Conventional rehabilitation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled studyRandomized controlled study
Masking:
Single (Outcomes Assessor)
Masking Description:
The assessor will be blind to group allocation.
Primary Purpose:
Treatment
Official Title:
The Investigation of the Effects of Robot-Assisted Rehabilitation on Respiratory Parameters, Dyspnea and Functional Capacity in Individuals With Stroke
Actual Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
Mar 30, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: 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.

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.

Active Comparator: Control Group

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

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.

Outcome Measures

Primary Outcome Measures

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

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

  2. Maximal inspiratory pressure [Change from Baseline Maximal inspiratory pressure at 6 weeks]

    Mouth pressure will be assessed to document inspiratory muscle strength

  3. Maximal expiratory pressure [Change from Baseline Maximal expiratory pressure at 6 weeks]

    Mouth pressure will be assessed to document expiratory muscle strength

  4. Peak Expiratory Flow Rate [Change from Baseline Peak Expiratory Flow Rate at 6 weeks]

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

Secondary Outcome Measures

  1. Peak cough flow [Change from Baseline Peak cough flow at 6 weeks]

    Peak cough flow will be measured in triplicate during the "maximal coughing manoeuvre" with a digital PEFmeter.

  2. 6 Minutes Walking Test [Change from Baseline 6 Minutes Walking Test at 6 weeks]

    The 6 minutes walk test is a sub-maximal exercises test use to assess aerobic capacity and endurance.

  3. Time Up and Go Test [Change from Baseline Time Up and Go Test at 6 weeks]

    The test evaluates the dynamic balance and mobility.

  4. Dyspnea-12 Scale [Change from Baseline Dyspnea-12 Scale at 6 weeks]

    The dyspnea perception will be measured with this scale. There are 12 descriptor items on this scale ranging none (0), mild (1), moderate (2) or severe (3). It provides an overall score for breahtlessness severity that incorporates seven physical items and five affective items.

  5. Satisfaction survey [At 6 weeks]

    This text is used to assess patients' satisfaction. Evaluation will be scored between c0-5 as a verbal response. 0 = not at all satisfied, 5 = very satisfied.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Biruni University Istanbul Turkey 34010

Sponsors and Collaborators

  • Biruni University

Investigators

  • Study Chair: Buket AKINCI, Assoc.Prof., Biruni University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Buket AKINCI, Assoc.Prof., Biruni University
ClinicalTrials.gov Identifier:
NCT05550311
Other Study ID Numbers:
  • 65-22-10
First Posted:
Sep 22, 2022
Last Update Posted:
Nov 16, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Buket AKINCI, Assoc.Prof., Biruni University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2022