NCT06757972

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

December 26, 2024

Last Update Submit

December 26, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    12 Months

Study Arms (2)

Interventional group I

EXPERIMENTAL
Combination Product: Tele Rehab

Interventional group II

ACTIVE COMPARATOR
Diagnostic Test: Formal Rehab

Interventions

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.

Interventional group I
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

Interventional group II

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Superior University CRC

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2024

First Posted

January 3, 2025

Study Start

March 1, 2024

Primary Completion

August 1, 2024

Study Completion

March 1, 2025

Last Updated

January 3, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations