Stroke
Conditions
Keywords
thermal stimulation, lower extremity, temperature, efficacy
Brief summary
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.
Detailed description
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.
Interventions
OTHERthermal stimulation
hot and cold/warm and cool pads applying.
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Hsin-Wen Hsu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | 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. |
| The change score from baseline to post-treatment and baseline to 1M follow-up in the Functional Ambulation Category (FAC) | 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. |
| The change score from baseline to post-treatment and baseline to 1M follow-up in the Barthel Index | 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
| Measure | Time frame | Description |
|---|---|---|
| The change score from baseline to post-treatment and baseline to 1M follow-up in the Postural Assessment Scale for Stroke Patients (PASS) | 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. |
| The change score from baseline to post-treatment and baseline to 1M follow-up in the Modified Ashworth Scale | 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. |
Countries
Taiwan
Outcome results
None listed