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Gait Speeds and Demands in Chronic Stroke Patients: A Multi-dimensional Investigation

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Treadmill walking training with random speed changes
Treadmill walking training with blocked speed changes
Sponsored by
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, gait, dual tasks, motor learning

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with first stroke for at least 6 months
  • Able to walk for at least 20 minutes independently without exhaustion
  • Residual gait deficits
  • Resting blood pressure is lower than 150/90 mmHg

Exclusion Criteria:

  • Unable to follow experimental instructions during the process
  • Any pain, inflammation, or other neuromuscular or musculoskeletal conditions in the lower limbs that affect walking ability
  • Unstable health problems

Sites / Locations

  • National Cheng Kung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

training with random speed changes

training with blocked speed changes

Arm Description

Walking training on treadmill with random speed changes, that is, random sequence of several different walking speeds

Walking training on treadmill with blocked speed changes, that is a steady progression of faster walking speed.

Outcomes

Primary Outcome Measures

stride characteristics
Wearable movement sensors are used to measure stride characteristics, such step length, gait velocity, under different walking conditions (normal, narrow based, dual task)

Secondary Outcome Measures

Full Information

First Posted
June 15, 2020
Last Updated
September 3, 2021
Sponsor
National Cheng Kung University
Collaborators
Tainan Hospital, Ministry of Health and Welfare
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1. Study Identification

Unique Protocol Identification Number
NCT04436536
Brief Title
Gait Speeds and Demands in Chronic Stroke Patients: A Multi-dimensional Investigation
Official Title
Gait Speeds and Demands in Chronic Stroke Patients: A Multi-dimensional Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University
Collaborators
Tainan Hospital, Ministry of Health and Welfare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study investigated the effect of treadmill walking training with and without random speed changes in persons in the chronic stage of stroke. It was hypothesized that random speed change group will show less attention and balance demands for speed change in level walking.
Detailed Description
This study includes chronic stroke patients who will be randomly assigned to blocked or random walking speed change group to receive 30 min per session, 3 sessions per week for 2 weeks' walking training on a treadmill. The outcome measures include gait characteristics under 3 tasks x 3 speed conditions x 2 attention conditions on an obstacle-free walk way. The three tasks are normal walking, narrow based walking and obstacle crossing. The three speed conditions are constant (preferred) speed, speeding up (preferred to maximum speed), and slowing down (maximum to preferred speed). The two attention conditions are none and serial subtraction of 3 during walking. Clinical sensorimotor function assessment, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale will be conducted for subject characterization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, gait, dual tasks, motor learning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
training with random speed changes
Arm Type
Experimental
Arm Description
Walking training on treadmill with random speed changes, that is, random sequence of several different walking speeds
Arm Title
training with blocked speed changes
Arm Type
Active Comparator
Arm Description
Walking training on treadmill with blocked speed changes, that is a steady progression of faster walking speed.
Intervention Type
Other
Intervention Name(s)
Treadmill walking training with random speed changes
Intervention Description
Participants were asked to walk in different gait speed randomly on the treadmill (80%, 90%, 100%, 110% and 120% of preferred speed). The training speed would be changed in every 15 seconds in 2-minutes-section. 2 minutes/ section, 10 sections/ day, 3 days/ week, 2 weeks. 1 minute rest time would be held between sections.
Intervention Type
Other
Intervention Name(s)
Treadmill walking training with blocked speed changes
Intervention Description
Participants were asked to walk in same gait speed on the treadmill per day (80%, 90%, 100%, 110% and 120% of preferred speed, respectively). 2 minutes/ section, 10 sections/ day, 3 days/ week, 2 weeks. 1 minute rest time would be held between sections.
Primary Outcome Measure Information:
Title
stride characteristics
Description
Wearable movement sensors are used to measure stride characteristics, such step length, gait velocity, under different walking conditions (normal, narrow based, dual task)
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with first stroke for at least 6 months Able to walk for at least 20 minutes independently without exhaustion Residual gait deficits Resting blood pressure is lower than 150/90 mmHg Exclusion Criteria: Unable to follow experimental instructions during the process Any pain, inflammation, or other neuromuscular or musculoskeletal conditions in the lower limbs that affect walking ability Unstable health problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Sang-I, PhD
Phone
+886-6-235-3535
Ext
5020
Email
lin31@mail.ncku.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Pei-Yun, PhD
Phone
+886-6-235-3535
Ext
5936
Email
peiyunlee@mail.ncku.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Sang-I, PhD
Organizational Affiliation
National Cheng Kung University
Official's Role
Study Chair
Facility Information:
Facility Name
National Cheng Kung University
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Sang-I, PhD
Phone
+886-6-235-3535
Ext
5020
Email
lin31@mail.ncku.edu.tw

12. IPD Sharing Statement

Learn more about this trial

Gait Speeds and Demands in Chronic Stroke Patients: A Multi-dimensional Investigation

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