- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06757972
Effect of Tele Rehabilitation in Breaking Barriers With Mobility Impairments in Rural Areas (RCT)
December 26, 2024 updated by: Muhammad Naveed Babur, Superior University
Effect of Tele Rehabilitation in Breaking Barriers With Mobility Impairments in Rural Areas: a Randomized Controlled Trial
Tele-rehabilitation offers remote healthcare services via telecommunication technology to patients who face challenges in accessing traditional in-person rehabilitation.
This randomized controlled trial investigated the effectiveness of tele-rehabilitation in overcoming mobility impairments in rural Pakistan.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
A total of 92 participants, equally divided into intervention and control groups, were assessed.
The intervention group received a 6-month tele-rehabilitation program, including video consultations, home visits, structured calls, and text messages.
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Punjab
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Lahore, Punjab, Pakistan
- Superior University CRC
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- People will be eligible for participation if they have had any disorder causing mobility impairment,
- Lives in rural areas,
- Are over the age of 20,
- Have been discharged from inpatient, outpatient and community physiotherapy living in their home, (Saywell, Vandal et al. 2012)
- Have medical approval from their general practitioner to engage in low to medium level exercise programs,
- At least 3 score on telephone cognitive screening questionnaire (Callahan, Unverzagt et al. 2002)
- Have limitation in mobility, physical function of arm, leg or both.
Exclusion Criteria:
- If they have confirmed cerebellar or brain stem stroke,
- Tele rehabilitation involvement require frequent communication with physiotherapist so using interpreter is considered impractical,
- Participants enrolled in other rehabilitation programs,
- Lack of necessary devices (e.g, internet, smartphone, tablet, computer) for tele rehabilitation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interventional group I
|
Tele rehabilitation intervention is 6 months standardized program aimed to provide special rehabilitation services to patients with mobility impairments in rural areas without the need for them to travel to healthcare facility in big cities.
The program consists of standard exercises addressing key components of mobility impairments.
|
|
Active Comparator: Interventional group II
|
After formal rehabilitation is completed, some impaired mobility victims re-access services; no attempt will be made to stop the control group from accessing further care, in either a public or private setting.
However, physical activity participation will be assured during monthly phone call by a blinded -research assistant.
Participants in this group will undergo three assessments at baseline, 6 and 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale
Time Frame: 12 Months
|
The scale consists of 14 tasks that a healthcare provider scores on a scale from 0 to 4. The higher the score, the better your balance.
It's a straightforward, reliable test providers use to assess functional balance
|
12 Months
|
|
Quality of Life (QOL)
Time Frame: 12 Months
|
The QOLS scores are summed so that a higher score indicates higher quality of life.
Average total score for healthy populations is about 90.
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2024
Primary Completion (Actual)
August 1, 2024
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
December 26, 2024
First Submitted That Met QC Criteria
December 26, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 26, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSRSW/Batch-Fall22/751
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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