NCT05614141

Brief Summary

It was planned to examine the effects of robot-assisted walking training supported by virtual reality on cognitive functions, quality of life and activities of daily living in individuals with subacute stroke. In this context, only conventional physiotherapy was applied to one group, while the other group was given exercises with Lokomat in addition to conventional physiotherapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 17, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

9 months

First QC Date

November 5, 2022

Last Update Submit

November 11, 2022

Conditions

Keywords

LokomatAugmented Performance Feedback

Outcome Measures

Primary Outcomes (1)

  • MOCA Score

    Montreal Cognitive Assessment (MOCA) assesses eight cognitive functions. These are attention and concentration, executive functions, memory, language, visual structuring, abstract thinking, computation, and orientation.

    6 weeks after treatment

Secondary Outcomes (2)

  • Lawton&Brody Score

    6 weeks after treatment

  • SS-QOL Score

    6 weeks after treatment

Study Arms (2)

Study Group

Device: Lokomat Augmented Performance FeedbackOther: Conventional Physiotherapy

Control Group

Other: Conventional Physiotherapy

Interventions

All participants will exercise with Lokomat Augmented Performance Feedback for six weeks. Augmented Performance Feedback has different virtual reality games.

Study Group

Conventional physiotherapy includes stretching, strengthening, balance, coordination and walking exercises under the guidance of a physiotherapist.

Control GroupStudy Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The research will be carried out with individuals with subacute stroke. Participation in the research is based on a voluntary basis.

You may qualify if:

  • First Stroke
  • Subacut stroke (from 21 days to 180 days)
  • Can do Lokomat exercises

You may not qualify if:

  • incompatibility to lokomat (Femur lenght problems, severe cognitive impairment, excess weight etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, 06000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc PT

Study Record Dates

First Submitted

November 5, 2022

First Posted

November 14, 2022

Study Start

August 17, 2022

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations