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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04436536
• Other study ID #: A-BR-107-101-T
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 26, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2021
• Source: National Cheng Kung University
• Contact: Lin Sang-I, PhD
• Phone: +886-6-235-3535
• Email: lin31[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Treadmill walking training with random speed changes
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.
• Treadmill walking training with blocked speed changes
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.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
National Cheng Kung University	Tainan Hospital, Ministry of Health and Welfare

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 weeks