NCT04875910

Brief Summary

A good rehabilitation program may not be accessible for all individuals living with stroke due to cost, transportation and compliance. Telerehabilitation is an alternative health care program that may help in overcoming this issue. In this study we aim to find if the use of telerehabilitation in Saudi Arabia would improve balance and walking in stroke survivors during this pandemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
Last Updated

May 6, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

May 1, 2021

Last Update Submit

May 3, 2021

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Change of balance confidence -The Activities- specific balance confidence (ABC) scale

    Consists of 16 items scored from 0% to 100%, with 0 % equate no confidence and 100% equate total confidence. The higher score indicates higher balance confidence

    pre and post intervention (1st and 4th week)

Secondary Outcomes (2)

  • Change in lower extremity function - The lower extremity functional scale (LEFS)

    pre and post intervention (1st and 4th week)

  • Change in Quality of life - Stroke Specific Quality Of Life scale (SS-QOL

    pre and post intervention (1st and 4th week)

Study Arms (1)

Stroke survivors participants

EXPERIMENTAL

Subjects who have been diagnosed with stroke 6 months or more. 1)Either right and left hemiparesis. 2) Subjects able to walk with or without assistive device. 3) age between 40-80. 4) Subjects can understand and follow commands. Exclusion criteria is: 1) subjects with uncontrolled Blood pressure, heart rate or breathing problems. 2) Having an orthopedic problem or

Other: Home-based exercise program

Interventions

Home-based exercise programOTHER

The exercise program will include task specific training to improve balance and the training will progress every two weeks. A Physical therapist will be following up and monitoring the participants adherence to the training by audio or video call. The exercise program for Week 1: Sit to Stand 5 times, Steps forward, backward and to the sides 5 times, 10 meters walk. 45 minutes session /3 times per week. Week 2: Sit to stand 10 times, Steps forward, backward and to the sides 5 times , Sit and reach 5 min for each hand and walk for 15 meters. 45 minutes session, 3 times per week. Week3 Sit to stand 10 times, Step on bench 5 times, Stand and reach 5 and walk for 15 meters. 45 minutes session, 3 times per week. Week 4 Stand and reach 5 times, Step on bench 10 times, climbing stairs (5 steps flight stairs up and down) and walk for 20 meters. 50 minutes session, 3 times per week.

Stroke survivors participants

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who have been diagnosed with stroke 6 months or more.
  • Either right or left hemiparesis.
  • Subjects able to walk with or without assistive device.
  • age between 40-70. 5) Subjects can understand and follow commands.

You may not qualify if:

  • subjects with uncontrolled Blood pressure, heart rate or breathing problems.
  • Having an orthopedic problem or pain that limits walking and standing.
  • Subject with vestibular disorders.
  • Subjects with cognitive disorders. 5) Subjects with hemi spatial neglect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud university

Riyadh, 11451, Saudi Arabia

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Almarwani, PhD

    Assistant professor at King Saud university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's student

Study Record Dates

First Submitted

May 1, 2021

First Posted

May 6, 2021

Study Start

March 1, 2021

Primary Completion

April 28, 2021

Study Completion

April 28, 2021

Last Updated

May 6, 2021

Record last verified: 2021-03

Locations

SA(1)