Skip to main content
OpenTrials
Completed

NCT Number: NCT01668420

Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke

The thermal stimulation have been proven effective in upper extremity of stroke patients. Therefore, this study explored the efficacy of thermal stimulation in lower extremity of stroke patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 807

About this study

There are two groups of stroke patients (onset > 3 months) in this study. The independent factor is temperature of the alternated heat and cold applying.

Who can participate

Healthy volunteers accepted: No

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

The inclusive criteria:

  • first-ever stroke
  • stroke onset > 3 months and < 3 years before the study enrollment
  • unilateral hemiplegia
  • ability to sit on a chair > 30 minutes independently
  • able to follow verbal instructions
  • age between 18 y/o and 80 y/o
  • be willing to participate in this study and gave their informed consent

The exclusive criteria:

  • skin disease, skin injuries, burns, or fresh scars over the TS application area
  • contraindication of ice or heat application
  • speech disorder or global aphasia
  • musculoskeletal or cardiac disorders that could potentially interfere
  • diabetic history or sensory impairment attributable to neuropathy.

Treatment and study plan

thermal stimulation

Other

hot and cold/warm and cool pads applying.

Other names: Thermal stimulation (FIRSTEK, Model-B401L,local company).

Primary outcomes

  1. The change score from baseline to post-treatment and baseline to 1M follow-up in the lower-limb subscale of the Stroke Rehabilitation Assessment of Movement(LE-STREAM)

    Time frame: pre, post, 1M follow-up

    The lower-limb subscale of the Stroke Rehabilitation Assessment of Movement (LE-STREAM) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.

  2. The change score from baseline to post-treatment and baseline to 1M follow-up in the mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM)

    Time frame: pre, post, 1M follow-up

    The mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.

  3. The change score from baseline to post-treatment and baseline to 1M follow-up in the Functional Ambulation Category (FAC)

    Time frame: pre, post, 1M follow-up

    Functional Ambulation Category (FAC) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.

  4. The change score from baseline to post-treatment and baseline to 1M follow-up in the Barthel Index

    Time frame: pre, post, 1M follow-up

    Barthel Index (BI) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.

Secondary outcomes

  1. The change score from baseline to post-treatment and baseline to 1M follow-up in the Postural Assessment Scale for Stroke Patients (PASS)

    Time frame: pre, post, 1M follow-up

    Postural Assessment Scale for Stroke Patients (PASS) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.

  2. The change score from baseline to post-treatment and baseline to 1M follow-up in the Modified Ashworth Scale

    Time frame: pre, post, 1M follow-up

    Modified Ashworth Scale (MAS) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.

Sponsors and collaborators

Lead sponsor

Hsin-Wen Hsu

Other

Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 20, 2012
Registry last updated
Nov 9, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.