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

NCT01668420 | Completed

• 1 other identifier: KMUH-IRB-980332
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

thermal stimulation; lower extremity; temperature; efficacy

Outcome Measures

Primary Outcomes (4)

• 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)

  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.

  pre, post, 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)

  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.

  pre, post, 1M follow-up

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

  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.

  pre, post, 1M follow-up

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

  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.

  pre, post, 1M follow-up

Secondary Outcomes (2)

• 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

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

  pre, post, 1M follow-up

Study Arms (2)

noxious thermal stimulation

EXPERIMENTAL

Heat-pain:46-47°C and Cold-pain:2-3°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given

Other: thermal stimulation

thermal stimulation (innocuous)

ACTIVE COMPARATOR

Heat:40-41°C and Cold:23-24°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given

Other: thermal stimulation

Interventions

thermal stimulation OTHER

hot and cold/warm and cool pads applying.

Also known as: Thermal stimulation (FIRSTEK, Model-B401L,local company).

noxious thermal stimulation; thermal stimulation (innocuous)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Hsin-Wen Hsu: lead
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 807, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Hsin-Wen Hsin, graduated

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physical therapist (graduated student)

Study Record Dates

• First Submitted: August 12, 2012
• First Posted: August 20, 2012
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 9, 2012

Record last verified: 2012-11

Locations

TW (1)