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Development and Evaluation of a Novel Portable Robotic Gait Rehabilitation in Chronic Stroke

NCT03444688 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-04-10

No results posted yet for this study

Summary

The aims of this study is to test the training effects of the robotic walker. This study will compare the effectiveness of 2 different types of gait training protocols in chronic stroke patients, 1) conventional gait training (CT, control group), and 2) gait rehabilitation with the new walker modified after 1st stage (WT, experimental group).

Conditions

Interventions

OTHER

Conventional Gait Training

Subjects allocated to the CT group will first perform active assisted or passive range of motion of the lower limbs including ankle, knee, and hip joint in the supine position for 10 minutes. They will then perform conventional gait and balance therapy based on the proprioceptive neuromuscular facilitation (PNF) concept for 15 minutes. They will be given a 5 minutes rest. Finally, the CT subjects will undergo the over-ground gait training with or without aid or orthoses and with manual assistance from senior physiotherapist for 15 minutes, depending on the individual subject's abilities.

DEVICE

Gait rehabilitation with walker

For WT group, subjects will first go through active assisted or passive range of motion of the lower limbs including ankle, knee, and hip joint in the supine position for 10 minutes. The main therapy consists of 2 parts with 5 minutes rest in between. During part 1, subjects will be trained on the robotic walker with the help of active body weight support (BWS) and functional electrical stimulation (FES) for 15 minutes with pelvic motion support function and lateral balance function being continuously provided. During part 2, subjects will also receive resistance/assistance forces on top of the BWS and FES training for 15 minutes.

Sponsors & Collaborators

Principal Investigators

  • Santhosh Kumar Seetharaman · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-02
Primary Completion
2018-12-10
Completion
2018-12-10

Countries

  • Singapore

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03444688 on ClinicalTrials.gov