NCT03736200

Brief Summary

High intensity motion improves motor functions and quality of life in a neurologist. The investigators want to improve the clinical condition and quality of life of post-STROKE participants with a special sensory motor and visual motor agility therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Sep 2018

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

Study Start

First participant enrolled

September 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

April 28, 2020

Status Verified

September 1, 2018

Enrollment Period

1.2 years

First QC Date

November 1, 2018

Last Update Submit

April 27, 2020

Conditions

Keywords

balancemovementexergamingposturequality of lifegait

Outcome Measures

Primary Outcomes (5)

  • Quality of life measured by Barthel index

    questionnaire

    4 weeks

  • gait / functional test

    6 minute walk test (m)

    4 weeks

  • balance test

    Berg balance test

    4 weeks

  • postrural control test

    posturography (mm)

    4 weeks

  • Quality of life measured by EQ5-D scale

    questionnaire

    4 weeks

Study Arms (3)

Exergaming 1/day

ACTIVE COMPARATOR

Post stroke group that received 4 weeks of intensive therapy. (1/day)

Other: Exergaming group

physiotherapy

ACTIVE COMPARATOR

Post stroke group that received 4 weeks of traditional physiotherapy.

Other: Physiotherapy

Exergaming 2/day

ACTIVE COMPARATOR

Post stroke group that received 4 weeks of intensive therapy. (2/day)

Other: Exergaming group 2/day

Interventions

Neurorehabilitation - 4-week-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (1/day)

Also known as: EXE group
Exergaming 1/day

Physiotherapy 4-week-long.

Also known as: Physio group
physiotherapy

Neurorehabilitation - 4-week-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (2/day)

Also known as: EXE2 group
Exergaming 2/day

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • post stroke
  • MWT : 120\>
  • minimum after stroke 2 weeks

You may not qualify if:

  • Sever heart problem
  • sever demeanor
  • alcoholism
  • drug problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

József Tollá

Kaposvár, Somogy County, 7400, Hungary

Location

Related Publications (1)

  • Tollar J, Nagy F, Csutoras B, Prontvai N, Nagy Z, Torok K, Blenyesi E, Vajda Z, Farkas D, Toth BE, Repa I, Moizs M, Sipos D, Kedves A, Kovacs A, Hortobagyi T. High Frequency and Intensity Rehabilitation in 641 Subacute Ischemic Stroke Patients. Arch Phys Med Rehabil. 2021 Jan;102(1):9-18. doi: 10.1016/j.apmr.2020.07.012. Epub 2020 Aug 27.

Related Links

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 1, 2018

First Posted

November 9, 2018

Study Start

September 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

April 28, 2020

Record last verified: 2018-09

Locations