Balance; DistortedNCT06008665
Effects of Action Observation Therapy With Otago Exercises on Balance and Quality of Life in Older Adults
A study testing Action Observation Therapy and Otago Exercises and Otago Exercises in people with Balance; Distorted, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study is to determine to see the effect of action observation therapy with otago exercise on Balance and Quality Of Life. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance; Distorted
- What is being tested?
- Action Observation Therapy and Otago Exercises and Otago Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Jul 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both genders
- Participant experience fall > one time in last 6 months.
- Participants having Berg Balance score between 20 to 40
Who cannot join
- ●Abnormalities in visual, auditory, or vestibular system
- Limb defects
- History of recent fractures
- Participants with Cardiovascular, Cerebrovascular disease or traumatic brain injury and Epilepsy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Waqar Awan Awan
Islamabad, 44000
Waqar Awan Awan, PhD, 03335348846, waqar.ahmed@riphah.edu.pk
About this study
This study is to determine to see the effect of action observation therapy with otago exercise on Balance and Quality Of Life.
Read the detailed description
This study is designed to reduce the Fall and balance problems and increase the quality of life in older adults. Balance, which declines with aging, is a complex sensory-motor process in which the visual, vestibular, and musculoskeletal systems work cooperatively to produce postural stability and loss of balance control causes falls, resulting in severe injuries, such as fractures, causing longstanding pain, lower quality of life, disability, and even death.
Interventions include balance and postural control that can help older people to avoid falling, through tai chi methods, gait training, strengthening exercises, and balance training programs.
The Otago Exercise Program comprises muscle strength exercises, balance training, and walking. The Otago workout program is based on individual tolerance, consisting of strengthening, balance, walking, and aerobic activities, and can be done at home environment Action observation is a cognitive intervention training strategy that involves observing other people's performance in order to promote motor learning.
Participants were instructed to watch a video on a screen while comfortably seated in a chair with armrests. They were not allowed to follow along or engage in any movement while watching the video. After the watching video of each component of otago exercises the exercises performed by participant based on the content of the video.
- Conditions
- Balance; Distorted
- Being tested
- Action Observation Therapy and Otago Exercises, Otago Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation Therapy and Otago ExercisesOther
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.
Otago ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Otago Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Baseline to 12th week
Secondary outcomes (1)
Short Form 36
The SF 36 is use to measure the Quality of Life
Measured: Baseline to 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start12 Jul 2023
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance; DistortedStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Education Research Foundation (HERF)
- Responsible party
- Sponsor
- Investigators
- Waqar Ahmed Awan, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008665
- Sponsor's protocol ID
- 01345
- Status last verified
- Aug 2023
- First submitted
- 10 Jul 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Action Observation Therapy With Otago Exercises on Balance and Quality of Life in Older Adults
- ClinicalTrials.gov ID
- NCT06008665
- Acronym / sponsor ID
- 01345
- Conditions
- Balance; Distorted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Collaborators
- Health Education Research Foundation (HERF)
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 23 Aug 2023 (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.
This study is to determine to see the effect of action observation therapy with otago exercise on Balance and Quality Of Life.
Detailed description
This study is designed to reduce the Fall and balance problems and increase the quality of life in older adults. Balance, which declines with aging, is a complex sensory-motor process in which the visual, vestibular, and musculoskeletal systems work cooperatively to produce postural stability and loss of balance control causes falls, resulting in severe injuries, such as fractures, causing longstanding pain, lower quality of life, disability, and even death.
Interventions include balance and postural control that can help older people to avoid falling, through tai chi methods, gait training, strengthening exercises, and balance training programs.
The Otago Exercise Program comprises muscle strength exercises, balance training, and walking. The Otago workout program is based on individual tolerance, consisting of strengthening, balance, walking, and aerobic activities, and can be done at home environment Action observation is a cognitive intervention training strategy that involves observing other people's performance in order to promote motor learning.
Participants were instructed to watch a video on a screen while comfortably seated in a chair with armrests. They were not allowed to follow along or engage in any movement while watching the video. After the watching video of each component of otago exercises the exercises performed by participant based on the content of the video.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action observation therapy with Otago exercise | Experimental | Other: Action Observation Therapy and Otago Exercises* 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. |
| Otago exercise | Active comparator | Other: Otago Exercises* 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both genders
- Participant experience fall > one time in last 6 months.
- Participants having Berg Balance score between 20 to 40
Key exclusion criteria (4 listed)
- ●Abnormalities in visual, auditory, or vestibular system
- Limb defects
- History of recent fractures
- Participants with Cardiovascular, Cerebrovascular disease or traumatic brain injury and Epilepsy
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 |
|---|---|---|
| Action Observation Therapy and Otago ExercisesStrength 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 | Action observation therapy with Otago exercise |
| Otago ExercisesStrength 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. | Other | Otago exercise |
Primary outcome
Berg Balance Scale
Time frame: Baseline to 12th week
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)
Time Up and Go test
Time frame: Baseline to 12th week
The Timed Up and Go test is to identify mobility and balance impairments in older adults. Score ≥12 seconds (Risk of Fall)
Functional Reach Test
Time frame: Baseline to 12th week
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)
1 secondary outcome
Short Form 36
Time frame: Baseline to 12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- 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.
Waqar Ahmed Awan, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Therapy and Otago Exercises and Otago Exercises in people with Balance; Distorted, run by Riphah International 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 3 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: status not confirmed, as of the sponsor's last update on 23 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waqar Ahmed Awan, PhD (+923335348846, waqar.ahmed@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: Baseline to 12th week). The study lists 3 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 23 Aug 2023.