NCT05931211

Brief Summary

This study will incorporate patients/ caregivers' perspectives to investigate the performance in daily activities of individuals with SMA and how it relates to their motor function abilities.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

June 30, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 7, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

June 26, 2023

Last Update Submit

July 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Revised Upper Limb Module

    The physiotherapist will perform a serious of motor test to evaluate the patient's upper limb motor function. This test is to observe the manual ability on different tasks in sitting position, including drawing along the path, opening Ziploc container, or lifting weight. And the therapist will score for each item. The Revised Upper Limb Module (RULM) are consist of 19 items. It takes about 15-20 minutes for testing.

    15-20 minutes

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disease that causes progressive muscle weakness and atrophy and eventually leads to loss of function.

You may qualify if:

  • Having a diagnosis of SMA with genetics confirmed as 5q SMA.
  • Above 3 years of age (capable of performing motor assessments).

You may not qualify if:

  • Having severe respiratory and other medical conditions precluding safe participation in standardized motor function tests.
  • Having any orthopedic surgery during the past 6 months.
  • Women who are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesNeuromuscular Diseases

Study Officials

  • Hsi-Wen Huang, MSc

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsi-Wen Huang, MSc

CONTACT

Fang-Yi Huang, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 5, 2023

Study Start

June 30, 2023

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

July 7, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations