Clinical trial NCT04192240: Weight-bearing Training in Stroke Patients.
Official title: Immediate Effects of Lower Limb Loading Training During Sit-to-stand and Stepping With and Without External Feedback in Ambulatory Individuals With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: cerebrovascular disease
rehabilitation
walking
balance
mobility
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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?

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight-bearing (WB) ability and WB symmetry
timeFrame: Prior to and immediately after complete training program in one session
Secondary outcomes:
measure: Walking speed using the 10 meter-walk test (10MWT)
timeFrame: Prior to and immediately after complete training program in one session
measure: Dynamic balance control using the Timed up and go test (TUGT)
timeFrame: Prior to and immediately after complete training program in one session
Other outcomes:
Locations:
city: Nai Muang
country: Thailand
facility: Faculty of Associated Medical Science
state: KhonKaen
Study officials:
affiliation: School of physical therapy, Faculty of Associated medical sciences, Khon Kaen University
name: Sugalya Amatachaya
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boukadida A, Piotte F, Dehail P, Nadeau S. Determinants of sit-to-stand tasks in individuals with hemiparesis post stroke: A review. Ann Phys Rehabil Med. 2015 Jun;58(3):167-72. doi: 10.1016/j.rehab.2015.04.007. Epub 2015 May 23.
citation: Lomaglio MJ, Eng JJ. Muscle strength and weight-bearing symmetry relate to sit-to-stand performance in individuals with stroke. Gait Posture. 2005 Oct;22(2):126-31. doi: 10.1016/j.gaitpost.2004.08.002.
citation: Park GD, Choi JU, Kim YM. The effects of multidirectional stepping training on balance, gait ability, and falls efficacy following stroke. J Phys Ther Sci. 2016 Jan;28(1):82-6. doi: 10.1589/jpts.28.82. Epub 2016 Jan 30.
citation: Tsaklis PV, Grooten WJ, Franzen E. Effects of weight-shift training on balance control and weight distribution in chronic stroke: a pilot study. Top Stroke Rehabil. 2012 Jan-Feb;19(1):23-31. doi: 10.1310/tsr1901-23.