NCT06008665

Brief Summary

This study is to determine to see the effect of action observation therapy with otago exercise on Balance and Quality Of Life.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 10, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

July 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

July 10, 2023

Last Update Submit

August 18, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Berg Balance Scale

    The Berg Balance Scale is a testing tool with high validity and reliability used to measure balance. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56. Score 0-20(High Risk of Fall), 21-40(Moderate Risk of Fall) and 41-54(Low Rosk of Fall)

    Baseline to 12th week

  • Time Up and Go test

    The Timed Up and Go test is to identify mobility and balance impairments in older adults. Score ≥12 seconds (Risk of Fall)

    Baseline to 12th week

  • Functional Reach Test

    The Functional Reach Test is a single item test developed as a quick screen for balance problems in older adults. Score \>6 inches (High Risk of Fall), 6-10 inches (Risk of Fall)

    Baseline to 12th week

Secondary Outcomes (1)

  • Short Form 36

    Baseline to 12th week

Study Arms (2)

Action observation therapy with Otago exercise

EXPERIMENTAL

* Participants' Instructions: * Watch a video on a 22-inch screen. * Screen positioned 1 meter away from them. * Comfortably seated in a chair with armrests. * No following along or movement allowed. * Video Features: Model in the video is 70 years old or older. Model similar to the participants. * Video Viewing: Duration: 17 minutes (1 minute per video). Supervised by the same investigator. Quiet environment during observation. * Physical Training Session: Supervised by a therapist. * Duration: 35 minutes (2 minutes max per session). * Based on content from the video. * Action Observation Training: Activities during the physical education workshops featured in the videos.

Other: Action Observation Therapy and Otago Exercises

Otago exercise

ACTIVE COMPARATOR

* Strength Training Component:Knee Flexor, Knee Extensor, Hip Adductors, Ankle Planter Flexors, Ankle Dorsi Flexors * Balance Training Component: * Activities include: Walking backwards, Walking in a figure of eight, Heel-toe walking, Standing on one leg, Walking on the heels, Walking on the toes, Heel-toe walking backwards, Standing up from a sitting position, Walking up stairs. * Training Frequency and Guidance: Exercises conducted three times a week,Guidance provided by a therapist. * Training Session Duration: Each session lasts for 35-40 minutes. * Warm-up and Cool-down:5-minute warm-up before each session and 5-minute cool-down after each session.

Other: Otago Exercises

Interventions

Strength Training Component:Knee Flexor, Knee Extensor, Hip Adductors, Ankle Planter Flexors, Ankle Dorsi Flexors Balance Training Component: Activities include: Walking backwards, Walking in a figure of eight, Heel-toe walking, Standing on one leg, Walking on the heels, Walking on the toes, Heel-toe walking backwards, Standing up from a sitting position, Walking up stairs. Training Frequency and Guidance: Exercises conducted three times a week,Guidance provided by a therapist. Training Session Duration: Each session lasts for 35-40 minutes. Warm-up and Cool-down:5-minute warm-up before each session and 5-minute cool-down after each session.

Action observation therapy with Otago exercise

Strength Training Component:Knee Flexor, Knee Extensor, Hip Adductors, Ankle Planter Flexors, Ankle Dorsi Flexors Balance Training Component: Activities include: Walking backwards, Walking in a figure of eight, Heel-toe walking, Standing on one leg, Walking on the heels, Walking on the toes, Heel-toe walking backwards, Standing up from a sitting position, Walking up stairs.

Otago exercise

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both genders
  • Participant experience fall \> one time in last 6 months.
  • Participants having Berg Balance score between 20 to 40

You may not qualify if:

  • ●Abnormalities in visual, auditory, or vestibular system
  • Limb defects
  • History of recent fractures
  • Participants with Cardiovascular, Cerebrovascular disease or traumatic brain injury and Epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Waqar Awan Awan

Islamabad, 44000, Pakistan

RECRUITING

Study Officials

  • Waqar Ahmed Awan, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Waqar Ahmed Awan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
One of my group is experimental and the other one is controlled
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2023

First Posted

August 23, 2023

Study Start

July 12, 2023

Primary Completion

October 30, 2023

Study Completion

November 30, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations