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

Phase 1

• Conditions: Stroke
• Interventions: Other: Treadmill walking training with random speed changes; Other: Treadmill walking training with blocked speed changes

• Registration Number: NCT04436536
• Lead Sponsor: National Cheng Kung University

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.

Study Timeline

• Study Start: 2020-02-26
• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-18
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-05
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
training with random speed changes	Treadmill walking training with random speed changes	Walking training on treadmill with random speed changes, that is, random sequence of several different walking speeds
training with blocked speed changes	Treadmill walking training with blocked speed changes	Walking training on treadmill with blocked speed changes, that is a steady progression of faster walking speed.

Primary Outcome Measures

Name	Time	Method
stride characteristics	2 weeks	Wearable movement sensors are used to measure stride characteristics, such step length, gait velocity, under different walking conditions (normal, narrow based, dual task)

Trial Locations

Locations (1)

National Cheng Kung University; 🇨🇳 Tainan, Taiwan