NCT03651479

Brief Summary

The aim of this study is to compare the effects of virtual and real boxing training in addition to neurodevelopmental training on cognitive status, upper extremity functions, balance and activities of daily living in hemiparetic stroke patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 10, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

January 18, 2020

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

August 10, 2018

Results QC Date

June 19, 2019

Last Update Submit

November 29, 2021

Conditions

Keywords

virtual realityboxingupper extremity functioncognitive functionbalance

Outcome Measures

Primary Outcomes (1)

  • Wolf Motor Function Test

    Wolf Motor Function Test (WFMT) quantifies upper extremity motor ability through the use of timed and functional tasks. The widely used version of the WMFT consists of 17 items, items 7 and 14 are related to subject strength and the other 15 to subject functional ability during various tasks. Performances are scored using a 6-point functional ability scale and the less affected upper extremity followed by the most affected side. The total score, also referred to as Functional Ability score (WMFT-FAS), is the sum of the 15 items score (with a 6-point ordinal score from 0 to 5). The maximum total score is 75 and minimum is 0. Lower scores indicating lower functional levels.

    8 weeks

Secondary Outcomes (5)

  • Minnesota Manual Dexterity Test

    8 weeks

  • Video Boxing Analysis of Punching

    8 weeks

  • Fullerton Advanced Balance Scale

    8 weeks

  • Addenbrooke's Cognitive Assessment

    8 weeks

  • Frenchay Activities Index

    8 weeks

Study Arms (2)

real boxing group

EXPERIMENTAL

In the real boxing (RB) group in addition to the NDT program, real boxing training will be given.

Other: real boxing training

virtual boxing group

EXPERIMENTAL

In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing.

Other: virtual boxing training

Interventions

In the real boxing (RB) group in addition to the NDT program, real boxing training will be given. Accordingly, the physiotherapist and the patient will wear boxing gloves and the patients will punch the physiotherapist's glove with a pre-specified treatment protocol. Resistance and frequencies between levels will be increased by the physiotherapist as the sessions progress. The RB group will have 30 minutes of real boxing training for 3 sessions per week for 8 weeks.

real boxing group

In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing. For the VB group, virtual boxing training will be held for 3 weeks 30 minutes a week for 8 weeks.

virtual boxing group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with first time ever stroke
  • Patients with hemiparesis
  • Patients who are between the ages of 18-70
  • Patients who has Mini Mental Test score above 23
  • Patients whose functional level is less than 4 according to the Modified Rankin Scale
  • Patients who has upper extremity spasticity lower than 3 on Modified Ashworth Scale

You may not qualify if:

  • Hypertension
  • Heart disease
  • Subluxation and fracture at the shoulder
  • Visual impairment
  • Limitation in passive normal joint movement in hemiplegic side
  • Botulinum toxin administration or surgical operation in the last 6 months patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, North Cyprus Via Mersin 10 Turkey, 99450, Cyprus

Location

Related Publications (2)

  • Park J, Gong J, Yim J. Effects of a sitting boxing program on upper limb function, balance, gait, and quality of life in stroke patients. NeuroRehabilitation. 2017;40(1):77-86. doi: 10.3233/NRE-161392.

    PMID: 27792020BACKGROUND
  • Sin H, Lee G. Additional virtual reality training using Xbox Kinect in stroke survivors with hemiplegia. Am J Phys Med Rehabil. 2013 Oct;92(10):871-80. doi: 10.1097/PHM.0b013e3182a38e40.

    PMID: 24051993BACKGROUND

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

There were problems caused by technology in the virtual reality therapy group for example; Freezing the image while playing game and the patient's position to move out of the camera area can not be detected

Results Point of Contact

Title
Asst. Prof. Dr. Gozde Iyigun
Organization
Eastern Mediterranean University

Study Officials

  • Gozde Iyigun, PhD

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty member

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 29, 2018

Study Start

November 10, 2018

Primary Completion

June 12, 2019

Study Completion

June 12, 2019

Last Updated

November 30, 2021

Results First Posted

January 18, 2020

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations