Trial Outcomes & Findings for Smartphone-based Wearable Telerehabilitation (NCT NCT04146454)

NCT ID: NCT04146454

Last Updated: 2026-05-20

Results Overview

The Usability and acceptability questionnaire (UAQ) is a self-reported questionnaire used by subjects to assess the usability and acceptability of the proposed smartphone-based wearable telerehabilitation system. The Usability and acceptability questionnaire (UAQ) has a comparative Likert scale survey (strongly disagree (1), disagree (2), neither disagree nor agree (3), agree (4), or strongly agree (5)), with 5 being very confident in using the system and 1 being not confident at all in using the system.

Recruitment status

COMPLETED

Target enrollment

9 participants

Primary outcome timeframe

Post-assessment (at the end of week 6)

Results posted on

2026-05-20

Participant Flow

The study originally planned to recruit 20 participants; however, recruitment was discontinued because of COVID-19 restrictions at the University of Houston. As a result, 9 participants were enrolled.

All 9 enrolled participants were assigned to the intervention arm. No participants were excluded or withdrawn before assignment.

Participant milestones

Participant milestones
Measure
Intervention
All participants were asked to perform 18 sessions (3 days per week for 6 consecutive weeks) at their home. Each day, one session included 24 trials (12 trials in each A/P and ML direction). They were told that a trial lasted approximately 1 min, followed by 20 seconds of rest between trials. It was recommended that they watched the smartphone's instructional video each day of their exercises. They were told to continue taking their anti-PD medications (no one changed medications).
Overall Study
STARTED
9
Overall Study
COMPLETED
7
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention
All participants were asked to perform 18 sessions (3 days per week for 6 consecutive weeks) at their home. Each day, one session included 24 trials (12 trials in each A/P and ML direction). They were told that a trial lasted approximately 1 min, followed by 20 seconds of rest between trials. It was recommended that they watched the smartphone's instructional video each day of their exercises. They were told to continue taking their anti-PD medications (no one changed medications).
Overall Study
Hip joint surgery
1
Overall Study
Other health reason
1

Baseline Characteristics

Smartphone-based Wearable Telerehabilitation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention
n=7 Participants
Participants were eligible if they were between stage 2 to 4 on the H\&Y scale.
Age, Categorical
<=18 years
0 Participants
n=30 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=30 Participants
Age, Categorical
>=65 years
7 Participants
n=30 Participants
Age, Continuous
69.86 years
STANDARD_DEVIATION 11.84 • n=30 Participants
Sex: Female, Male
Female
2 Participants
n=30 Participants
Sex: Female, Male
Male
5 Participants
n=30 Participants
Race (NIH/OMB)
American Indian or Alaska Native
4 Participants
n=30 Participants
Race (NIH/OMB)
Asian
0 Participants
n=30 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=30 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=30 Participants
Race (NIH/OMB)
White
0 Participants
n=30 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=30 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=30 Participants
Region of Enrollment
United States
9 participants
n=30 Participants
Range of limits of stability
5 Degrees
STANDARD_DEVIATION 1.3 • n=30 Participants

PRIMARY outcome

Timeframe: Post-assessment (at the end of week 6)

Population: Technology Acceptance Model (TAM) questionnaire

The Usability and acceptability questionnaire (UAQ) is a self-reported questionnaire used by subjects to assess the usability and acceptability of the proposed smartphone-based wearable telerehabilitation system. The Usability and acceptability questionnaire (UAQ) has a comparative Likert scale survey (strongly disagree (1), disagree (2), neither disagree nor agree (3), agree (4), or strongly agree (5)), with 5 being very confident in using the system and 1 being not confident at all in using the system.

Outcome measures

Outcome measures
Measure
Intervention
n=7 Participants
All participants were asked to perform 18 sessions (3 days per week for 6 consecutive weeks) at their home. Each day, one session included 24 trials (12 trials in each A/P and ML direction). They were told that a trial lasted approximately 1 min, followed by 20 seconds of rest between trials. It was recommended that they watched the smartphone's instructional video each day of their exercises. They were told to continue taking their anti-PD medications (no one changed medications).
Usability and Acceptability Questionnaire (UAQ)
4.86 Score on a scale
Standard Deviation 0.38

Adverse Events

Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Beom Chan Lee

University of Houston

Phone: 713-743-6369

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place