Mobility LimitationNCT06757972
Effect of Tele Rehabilitation in Breaking Barriers With Mobility Impairments in Rural Areas (RCT)
A study testing Tele Rehab and Formal Rehab in people with Mobility Limitation, run by Superior University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- Tele Rehab and Formal Rehab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mobility Limitation
- Being tested
- Tele Rehab, Formal Rehab
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele RehabCombination product
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.
Formal RehabDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Interventional group I | Experimental | Not described Receives: Combination Product: Tele Rehab |
| Interventional group II | Active comparator | Not described Receives: Diagnostic Test: Formal Rehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
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
Measured: 12 Months
Quality of Life (QOL)
The QOLS scores are summed so that a higher score indicates higher quality of life. Average total score for healthy populations is about 90.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Mar 2024
- Primary completion1 Aug 2024
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757972
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/751
- Status last verified
- Dec 2024
- First submitted
- 26 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tele Rehabilitation in Breaking Barriers With Mobility Impairments in Rural Areas: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06757972
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/751
- Conditions
- Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group I | Experimental | Combination Product: Tele Rehab |
| Interventional group II | Active comparator | Diagnostic Test: Formal Rehab |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele RehabTele 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. | Combination product | Interventional group I |
| Formal RehabAfter 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 | Diagnostic test | Interventional group II |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele Rehab and Formal Rehab in people with Mobility Limitation, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.