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OpenTrials
Completed

NCT Number: NCT04192240

Weight-bearing Training in Stroke Patients.

1. Are there differences in weight-bearing (WB) and WB symmetry immediately following STS and stepping training with or without using external feedback in ambulatory patients with stroke?

1. Are there differences in mobility immediately following STS and stepping training with or without using external feedback in ambulatory patients with stroke?

Completed

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Key information

Age range

40 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Associated Medical Science

Nai Muang, KhonKaen, 40002, Thailand

About this study

Subjects are patients with stroke, the age of over 40 years to 74 years, both males and females who are able to walk independently at least 10 meters. Most of them will be recruited from a tertiary rehabilitation center and communities. Subjects have to participate in STS and stepping training with and without using the external feedback for 1 time/condition with a wash-out period for 2 weeks (crossover design). The outcomes will be measured in terms of WB ability during STS and stepping, walking speed, and balance ability.

The primary outcomes were WB ability on the affected limb and WB symmetry. Secondary outcomes were walking speed and balance ability.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Independent ambulatory patients with chronic stroke (post-stroke time more than 6 months)
  • Age at least 40 years to 74 years
  • Body mass index (BMI) between 18.5- 29.9 kg/m^2
  • Ability of independent walking over at least 10 meters with or without a walking device
  • Ability to rise from a chair with or without using their arms
  • Ability to follow a command used in the study

Exclusion criteria

any conditions that may affect ambulatory ability or ability to participate in the study, such as

  • Auditory or visual deficits that are unable to be corrected by a hearing aid, glasses or contact lens
  • Musculoskeletal pain with a pain scale more than 5 out of 10 on a visual analog scale (VAS)
  • Deformity in the limbs or spine that affect ambulatory ability
  • Modified Ashworth Scale (MAS) more 2 score
  • Unstable cardiovascular, orthopedics, musculoskeletal, or neurological disease other than stroke.

Treatment and study plan

WB Training with external feedback

Other

WB during sit-to-stand and stepping with external feedback, follow by overground walking.

WB Training without external feedback

Other

WB during sit-to-stand and stepping without external feedback, follow by overground walking.

Primary outcomes

  1. Weight-bearing (WB) ability and WB symmetry

    Time frame: Prior to and immediately after complete training program in one session

Secondary outcomes

  1. Walking speed using the 10 meter-walk test (10MWT)

    Time frame: Prior to and immediately after complete training program in one session

  2. Dynamic balance control using the Timed up and go test (TUGT)

    Time frame: Prior to and immediately after complete training program in one session

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

Immediate Effects of Lower Limb Loading Training During Sit-to-stand and Stepping With and Without External Feedback in Ambulatory Individuals With Stroke

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 10, 2019
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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