StrokeNCT05557968
Action Observation Therapy for Lower Limb in Stroke
A study testing Conventional Therapy and Action Observation Therapy (AO) in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study focuses on the effects of Action Observation therapy on stair walking, balance and self-efficacy in chronic stroke patients. This study will be conducted in Helping Hands Institute of Rehabilitation Sciences and Shifa Surgical Hospital Mansehra. It is a Randomized Control Trial. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Conventional Therapy and Action Observation Therapy (AO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2022to 1 Mar 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 40-60 years.
- Both male and female.
- Those who can walk more than 10 steps.
- More than 6 months since stroke onset.
- Ability to follow the study instructions-Mini mental state examination (MMSE) score ≥25
- Baseline score of the Fugel Meyer assessment scale is between20 and 60.
- Score of 3 on Modified Rankin Scale (MRS).
Who cannot join
- Patients who cannot perform the active movement of upper limb in pre-stroke condition due to musculoskeletal problems.
- Cardiopulmonary diseases which could hinder their ability to participate in the rehabilitation program in this study.
- Patients with impaired cognition.
- Orthopedic injuries
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Helping hand institute of rehabilitation sciences
Mansehra
Sania Syed, MS NMPT*
Sania Syed, MS-(NMPT)*
About this study
Official title: Effects of Action Observation Therapy on Stair Walking, Balance, and Self-efficacy in Chronic Stroke
This study focuses on the effects of Action Observation therapy on stair walking, balance and self-efficacy in chronic stroke patients. This study will be conducted in Helping Hands Institute of Rehabilitation Sciences and Shifa Surgical Hospital Mansehra.
It is a Randomized Control Trial. Non probability convenient sampling technique will be used to assess a total number of 40 respondents. Questionnaires and consent forms will be filled by the respondents. Each patient will be screened by using a simple selection Performa relevant to inclusion and exclusion criteria.
Read more
Total 30 patients will be included in the study and then divided into two groups i.e. Action observation therapy and Convention Therapy group with 15 individuals in each. Each group will be assessed thrice i.e. pre, post and follow up surveys. Each of them will receive the convention therapy for 30 mins except for the Action Observation therapy (AOT) group, which will also receive the additional 30 minutes session of action observational training. Total 18 sessions, 3 days a week for a total of six weeks will be performed on each patient.
Fugel Meyer Assessment Scale for lower limb, Timed Up and Go test, Timed Stair Test, Step test and self-efficacy scale will be used for the assessment. Baseline assessments of both group will be done on 1st week before the application of protocol, second assessment will be done on 4th week and then final assessment will be done on 6th week of the protocol.
- Conditions
- Stroke
- Being tested
- Conventional Therapy, Action Observation Therapy (AO)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional TherapyOther
conventional therapy will be given for stroke patients and three assessments i.e. pre, post and follow up surveys, a session of 30 minutes, 3 times weekly for a six week period.
Total 18 sessions would be performed on each patient for six weeks
Action Observation Therapy (AO)Other
The video consists of :
- Ascending and descending the step box.
- Ascending and descending the stairs in the treatment room.
- Holding the handrails to climb and descend the stairs inside and outside the building.
- Climbing and descending the stairs inside and outside the building without holding the handle.
- Climbing and descending the sidewalk block
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy | Active comparator | 1. Active range of motion exercises.
2. Passive range of motion exercises
3. Balance exercises.
4. On-ground gait training without watching videos Receives: Other: Conventional Therapy |
| Action Observation Therapy (AO) | Experimental | Conventional therapy in addition to observing images related to stair walking will be observed and physical training will performed to imitate tasks with a physical therapist. While observing the image, they will be instructed to think that their body was performing the movement of the image Receives: Other: Action Observation Therapy (AO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugel Meyer assessment scale for lower limb
Lower limb subscale of Fugel-Meyer Assessment is a subscale measuring lower limb motor recovery. It examines movement, coordination, and reflex action of the hip, knee, and ankle in the supine, sitting, and standing positions. Each item is scored on a 3-point scale (0, cannot perform; 1, partially performs; 2, performs fully). The score range is 0 to 34, with higher scores indicating better lower limb motor performance
Measured: week 6
Berg Balance Scale
The Berg Balance Scale (BBS) is a functional balance measurement and consists of 14 items(30). Each item is a 5-point ordinal scale ranging from 0 to 4, with 0 indicating an inability to complete the task entirely and 4 indicating an ability to complete the task criterion. Scores can range from 0 to 56. The higher the score, the better the postural control
Measured: week 6
Timed Up and Down Stair Test
To determine the change in stair walking ability, a timed stair test (TST) is performed. TST is a functional evaluation tool that evaluates stair walking ability in daily life. The measurement method is to measure the time it takes for the person to start climbing the stairs according to the command of the examiner and come down from the end of the stairs. One stairway used in this study is 95 cm wide, 15 cm long, and 15 cm high, for a total of 12 spaces
Measured: week 6
Step test
A step test (ST) was used to determine the change in balance ability required for stair walking. ST is an evaluation tool that examines the dynamic balance ability in the standing posture of stroke patients. The ST is a reliable measurement tool when the number of steps is counted by either experienced or inexperienced examiners by viewing videotapes. As for the measurement method, the subject stands in front of a 7.5 cm high stool 5 cm and then counts the number of times while repeatedly raising and lowering one foot as quickly as possible for 15 seconds
Measured: week 6
Timed up and go test
The Timed up and go test (TUG) is the time measured when standing up, walking straight for 3m, turning, walking back to the chair, and sitting down. Time less than 10 seconds shows functional independence, and time more than 30 seconds demonstrates functional dependence
Measured: week 6
Secondary outcomes (1)
Self-efficacy scale
The self-efficacy scale (SES) is used to investigate the change in self-efficacy during stair walking in stroke patients. SES is a measure that can evaluate self-efficacy as a result of being able to successfully perform a specific action in stroke patients. The scale consists of a total of 10 items, and the item 'I am not confident in performing at all' is a 100-point scale from 1 point to 'I can do it with complete confidence' 10 points. A higher score means a higher sense of self-efficacy
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Oct 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Afridi, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557968
- Sponsor's protocol ID
- REC/letter-01246 Kainat
- Status last verified
- Dec 2022
- First submitted
- 23 Sep 2022
- Last updated
- 12 Dec 2022
- 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 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Action Observation Therapy on Stair Walking, Balance, and Self-efficacy in Chronic Stroke
- ClinicalTrials.gov ID
- NCT05557968
- Acronym / sponsor ID
- REC/letter-01246 Kainat
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 28 Sep 2022 (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 focuses on the effects of Action Observation therapy on stair walking, balance and self-efficacy in chronic stroke patients. This study will be conducted in Helping Hands Institute of Rehabilitation Sciences and Shifa Surgical Hospital Mansehra.
It is a Randomized Control Trial. Non probability convenient sampling technique will be used to assess a total number of 40 respondents. Questionnaires and consent forms will be filled by the respondents. Each patient will be screened by using a simple selection Performa relevant to inclusion and exclusion criteria.
Total 30 patients will be included in the study and then divided into two groups i.e. Action observation therapy and Convention Therapy group with 15 individuals in each. Each group will be assessed thrice i.e. pre, post and follow up surveys. Each of them will receive the convention therapy for 30 mins except for the Action Observation therapy (AOT) group, which will also receive the additional 30 minutes session of action observational training. Total 18 sessions, 3 days a week for a total of six weeks will be performed on each patient.
Fugel Meyer Assessment Scale for lower limb, Timed Up and Go test, Timed Stair Test, Step test and self-efficacy scale will be used for the assessment. Baseline assessments of both group will be done on 1st week before the application of protocol, second assessment will be done on 4th week and then final assessment will be done on 6th week of the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy | Active comparator | Other: Conventional Therapy1. Active range of motion exercises. 2. Passive range of motion exercises 3. Balance exercises. 4. On-ground gait training without watching videos |
| Action Observation Therapy (AO) | Experimental | Other: Action Observation Therapy (AO)Conventional therapy in addition to observing images related to stair walking will be observed and physical training will performed to imitate tasks with a physical therapist. While observing the image, they will be instructed to think that their body was performing the movement of the image |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 40-60 years.
- Both male and female.
- Those who can walk more than 10 steps.
- More than 6 months since stroke onset.
- Ability to follow the study instructions-Mini mental state examination (MMSE) score ≥25
Key exclusion criteria (4 listed)
- Patients who cannot perform the active movement of upper limb in pre-stroke condition due to musculoskeletal problems.
- Cardiopulmonary diseases which could hinder their ability to participate in the rehabilitation program in this study.
- Patients with impaired cognition.
- Orthopedic injuries
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 |
|---|---|---|
| Conventional Therapyconventional therapy will be given for stroke patients and three assessments i.e. pre, post and follow up surveys, a session of 30 minutes, 3 times weekly for a six week period. Total 18 sessions would be performed on each patient for six weeks | Other | Conventional Therapy |
| Action Observation Therapy (AO)The video consists of : 1. Ascending and descending the step box. 2. Ascending and descending the stairs in the treatment room. 3. Holding the handrails to climb and descend the stairs inside and outside the building. 4. Climbing and descending the stairs inside and outside the building without holding the handle. 5. Climbing and descending the sidewalk block | Other | Action Observation Therapy (AO) |
Primary outcome
Fugel Meyer assessment scale for lower limb
Time frame: week 6
Lower limb subscale of Fugel-Meyer Assessment is a subscale measuring lower limb motor recovery. It examines movement, coordination, and reflex action of the hip, knee, and ankle in the supine, sitting, and standing positions. Each item is scored on a 3-point scale (0, cannot perform; 1, partially performs; 2, performs fully). The score range is 0 to 34, with higher scores indicating better lower limb motor performance
Berg Balance Scale
Time frame: week 6
The Berg Balance Scale (BBS) is a functional balance measurement and consists of 14 items(30). Each item is a 5-point ordinal scale ranging from 0 to 4, with 0 indicating an inability to complete the task entirely and 4 indicating an ability to complete the task criterion. Scores can range from 0 to 56. The higher the score, the better the postural control
Timed Up and Down Stair Test
Time frame: week 6
To determine the change in stair walking ability, a timed stair test (TST) is performed. TST is a functional evaluation tool that evaluates stair walking ability in daily life. The measurement method is to measure the time it takes for the person to start climbing the stairs according to the command of the examiner and come down from the end of the stairs. One stairway used in this study is 95 cm wide, 15 cm long, and 15 cm high, for a total of 12 spaces
Step test
Time frame: week 6
A step test (ST) was used to determine the change in balance ability required for stair walking. ST is an evaluation tool that examines the dynamic balance ability in the standing posture of stroke patients. The ST is a reliable measurement tool when the number of steps is counted by either experienced or inexperienced examiners by viewing videotapes. As for the measurement method, the subject stands in front of a 7.5 cm high stool 5 cm and then counts the number of times while repeatedly raising and lowering one foot as quickly as possible for 15 seconds
Timed up and go test
Time frame: week 6
The Timed up and go test (TUG) is the time measured when standing up, walking straight for 3m, turning, walking back to the chair, and sitting down. Time less than 10 seconds shows functional independence, and time more than 30 seconds demonstrates functional dependence
1 secondary outcome
Self-efficacy scale
Time frame: week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- 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.
Ayesha Afridi, 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 Conventional Therapy and Action Observation Therapy (AO) in people with Stroke, 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 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: status not confirmed, as of the sponsor's last update on 12 Dec 2022. 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 Ayesha Afridi, PhD* (03325962212, ayesha.afridi@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugel Meyer assessment scale for lower limb (time frame: week 6). The study lists 5 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 12 Dec 2022.