NCT05833295

Brief Summary

investigation of the effects of walking for 20 minutes on the acute H/M ratio on flat ground, downhill slopes at -7.5 degrees and -15 degrees in patients who have had a stroke, have spasticity and are ambulatory. At the same time, the aim of the study is to obtain the clinical effectiveness of this walking pattern and control of the H/M ratio by checking the H/M ratio again after 5 sessions and 20 minutes of walking for the patients participating in the study.

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
21

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Apr 2023

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

First Submitted

Initial submission to the registry

March 28, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

April 24, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2024

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

March 28, 2023

Last Update Submit

April 26, 2023

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

  • the change in the H/M ratio after a 20-minute walk.

    Each participant will be evaluated for changes in the H/M ratio with an EMG device before the walk, on the 1st day of the walk, and on the 5th day of the walk.

    Day 0: Before the walk

  • the change in the H/M ratio after a 20-minute walk.

    Each participant will be evaluated for changes in the H/M ratio with an EMG device before the walk, on the 1st day of the walk, and on the 5th day of the walk.

    Day 1: First day of 20-minute walk

  • the change in the H/M ratio after a 20-minute walk.

    Each participant will be evaluated for changes in the H/M ratio with an EMG device before the walk, on the 1st day of the walk, and on the 5th day of the walk.

    Day 5: The fifth day of the 20-minute walk

Secondary Outcomes (16)

  • Modified Asworth Scale

    Day 0: Before the walk

  • Modified Asworth Scale

    Day 5: The fifth day of the 20-minute walk

  • Modified Tardeu Scale

    Day 0: Before the walk

  • Modified Tardeu Scale

    Day 5: The fifth day of the 20-minute walk

  • Walking test

    Day 0: Before the walk

  • +11 more secondary outcomes

Study Arms (3)

Walking on flat ground

EXPERIMENTAL

Patients will walk for 20 minutes at a 0% slope.

Procedure: Walking on flat ground

-%7.5 Downhill walking

EXPERIMENTAL

They will walk downhill for 20 minutes at a -(negative)7.5% gradient.

Procedure: Downhill walking

-%15 Downhill walking

EXPERIMENTAL

They will walk downhill for 20 minutes at a -(negative)15% gradient.

Procedure: Downhill walking

Interventions

Downhill walkingPROCEDURE

Change in the H/M ratio after a downhill walk.

-%15 Downhill walking-%7.5 Downhill walking
Walking on flat groundPROCEDURE

Change in the H/M ratio after a Walking on flat ground

Walking on flat ground

Eligibility Criteria

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

You may qualify if:

  • patients diagnosed with stroke between the ages of 18 and 65 Dec

You may not qualify if:

  • Other neurological disorders,
  • Expressive or receptive aphasias,
  • Severe heart disease,
  • A history of poorly controlled diabetes,
  • Active cancer,
  • Those who have been injected with botilinum toxin in the last 3 months,
  • Orthopedic conditions affecting the legs, a history of hip or knee replacement,
  • Serious simultaneous medical problems, such as peripheral nerve damage
  • Inability to comprehend verbal instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mamara Üniversitesi Tıp Fakültesi

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Burak Yıldız, Dr.

CONTACT

05546797417adaletli_26@hotmail.com

Özge Keniş Coşkun, MD

CONTACT

05058294947Ozgekenis@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Patients will be randomized into 3 groups. Clinical and electrophysiological tests before and after walking sessions will be performed by an unannounced researcher.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 27, 2023

Study Start

April 24, 2023

Primary Completion

May 24, 2023

Study Completion

April 24, 2024

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)