Efficacy of a Novel Anti-spasticity Orthosis on Spasticity, Muscle Function, and Quality of Life

The Effect of 6-Week Use of the newly designed anti-spasticity Orthosis on Spasticity, Muscle Function, and Quality of Life in Patients with Stroke and Multiple Sclerosis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230528058315N4

Enrollment

Registered

2025-12-02

Start date

2025-12-01

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: multiple sclerosis. Condition 2: hemiplegia. Multiple sclerosis Other specified paralytic syndromes

Interventions

Intervention group: Each participant will be evaluated under two conditions: at baseline without history of using an antispastic orthosis, and after six-week using the new antispastic orthosis on the

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: The presence of mild to moderate spasticity (according to the Modified Ashworth Scale) A history of stroke or multiple sclerosis at least 6 months prior to the study onset Ability to comprehend and cooperate

Exclusion criteria

Exclusion criteria: Presence of severe orthopedic conditions in the upper limb open skin wounds at the orthosis site concurrent use of other similar therapeutic devices

Design outcomes

Primary

Measure	Time frame
Spasm severity. Timepoint: At baseline and after six-week use of anti-spastic orthosis. Method of measurement: Modified Ashworth scale.;Quality of life. Timepoint: At baseline and after six-week use of anti-spastic orthosis. Method of measurement: the score of EQ-5D-3L questionnaire.;Muscle strength. Timepoint: At baseline and after six-week use of anti-spastic orthosis. Method of measurement: manual muscle testing.	—

Measure

Time frame

Spasm severity. Timepoint: At baseline and after six-week use of anti-spastic orthosis. Method of measurement: Modified Ashworth scale.;Quality of life. Timepoint: At baseline and after six-week use of anti-spastic orthosis. Method of measurement: the score of EQ-5D-3L questionnaire.;Muscle strength. Timepoint: At baseline and after six-week use of anti-spastic orthosis. Method of measurement: manual muscle testing.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNahid Tafti

Hamedan University of Medical Sciences

Na.Tafti@yahoo.com+98 81 3838 1571

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026