Activities of Daily LivingNCT06966076
Effect of Callisthenic Training on Mobility and ADL Performance in Spastic Diplegic Cerebral Palsy Patients
A study testing calisthenic training and Conventional physical therapy group in people with Activities of Daily Living and Postural Control, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Almost 2 to 3 out of every 1000 children have Cerebral palsy in Pakistan.Spastic type of CP is dominant about 75%, diplegia (40%) and hemiplegic are (35.5%).Spastic diplegics have tightness of lower limb more than upper limb.Their chief complaints are reduced mobility,impaired balance and coordination and lack of… Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Activities of Daily Living, Postural Control, Spasticity
- What is being tested?
- calisthenic training and Conventional physical therapy group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Sep 2024to 2 May 2025
- 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 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 5 and 13 years
- Able to accept and follow verbal instructions
- Able to participate in a training program
- Based on Gross Motor Function Classification System (GMFCS SCALE 1,2 and 3)
Who cannot join
- If they have controlled seizures
- If they suffered from any inflammatory, infectious diseases, cognitive deficiencies and any musculoskeletal deformity with chronic contracture that interfere with physical activity.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Thrapy
Islamabad, 44000
About this study
Almost 2 to 3 out of every 1000 children have Cerebral palsy in Pakistan.Spastic type of CP is dominant about 75%, diplegia (40%) and hemiplegic are (35.5%).Spastic diplegics have tightness of lower limb more than upper limb.Their chief complaints are reduced mobility,impaired balance and coordination and lack of postural control and stability.Calisthenic training is sort of strengthening exercises in which patient use his/her own body weight as a resistance.
Calisthenic training aims to reduce movement limitation,contracture formation and improves patient's mobility for daily transfers and ambulation,active participation of patient in indoor and outdoor activities and enhance postural stability and controle during routine tasks. The current study aims to determine the effects of calisthenic training on mobility and ADL performance in spastic diplegic cerebral palsy children aged 5-12 years fulfilling the GMFCS criteria levels 1-3. A randomized control trial will be conducted in multidisciplinary lab of FUCP, department of physical medicine and peads and rehabilitation of Fauji Foundation Hospital on the sample of 32 participants. The subjects will be randomized into two groups by sealed opaque envelope method. Baseline assessment would be done by using WEEFIM measurement assessment scale for mobility and ADL performance, pediatric balance assessment Scale for postural control. Data will be collected at baseline before intervention, after 3 weeks and finally after 6 weeks of intervention. Interventional group will be receiving calisthenic training and conventional physical therapy while control group will be receiving conventional physical therapy alone. Exercise training would be done for a total of 12 sessions for 6 weeks, twice a week with each session lasting 45 minutes. Analysis would be done by using SPSS version 21. Ethical approval will be obtained from ERC of FUSH. Informed written consent will be obtained from all participants.
Read the detailed description
OBJECTIVES OF STUDY
- To determine the affects of callisthenic exercises in comparison to conventional physical therapy on mobility, ADL perfrmance and quality of life in spastic diplegic cp children .
- To determine the affects of callisthenic exercises in comparison to conventional physical therapy on postural controle in spastic diplegic cp
HYPOTHESIS:
Alternate hypothesis:
- affect of calisthenic training in comparison to conventional physical therapy on mobility in spastic diplegic cp patients (p<0.05).
- 2HA- There will be statistically significant difference in the affect of calisthenic training in comparison to conventional physical therapy to improve ADL performance in spastic diplegic cp patients (p<0.05).
- 3HA- There will be statistically significant difference in the effect of calisthenic training in comparison to conventional physical therapy to improve postural controle in spastic diplegic cp patients (p<0.05).
NULL HYPOTHESIS
- 1H0 -There will be no statistically significant difference in the effect of calisthenic training in comparison to conventional physical therapy to improve ADL performance in spastic diplegic cp patients (p<0.05).
- 2H0 -There will be no statistically significant difference in the effect of calisthenic training in comparison to conventional physical therapy to improve mobility in spastic diplegic cp patients (p<0.05). 3H0 -There will be no statistically significant difference in the effect of calisthenic trainingin comparison to conventional physical therapy to improve postural controle in spastic diplegic cp patients (p<0.05).
Significanve of study:
As there is no any Conclusive evidence of calisthenic training more precisely for spastic diplegic cp children so this study will be helpful for patients and other health care proffessionals to implement this study in their clinical practice and for the patients in a way they can keep continue this treatment protocol in their home bound friendly environment by using their own body weights as a resistance after quiting from sessions of this research .
it will provide a treatment protocol for targeting calisthenic training to improve mobility, incorporate postural corrections and functional capacitance in spastic cp children .
This study will maximize the indoor functional independency in the cerebral palsy
- Conditions
- Activities of Daily Living, Postural Control, Spasticity, Mobility
- Being tested
- calisthenic training, Conventional physical therapy group
- Keywords
- calisthenic training, postural control, conventional PT, FES-I, dynamic gait index, TUG, berg balance scale, older adults, risk of fall, functional mobility, balance, dual task training, Otago exercise program
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calisthenic trainingProcedure or surgery
COMMAND AND TARGET MUSCLE GROUP
- LEG RAISES (LEG STRENGTH) LIE ON YOUR BACK WITH YOUR LEGS STRAIGHT. LIFT LEGS OFF THE GROUND IN FRONT. LOWER THEM BACK DOWN WITHOUT TOUCHING THE FLOOR. TARGETS HIP FLEXOR
- SIDE LEG RAISES (LEG STRENGTH) LIE ON YOUR BACK WITH YOUR LEGS STRAIGHT. LIFT LEGS OFF THE GROUND AND TAKE IT TO SIDE MAXIMALL WITHOUT TOUCHING THE FLOOR. TARGETS LOWER ABS AND HIP ABDUCTORS
- GLUTE BRIDGES ( BACK STRENGTH) LIE ON YOUR BACK WITH YOUR KNEES BENT. LIFT YOUR HIPS OFF THE GROUND, SQUEEZING YOUR GLUTES. LOWER AND REPEAT. TARGETS GLUTES AND HAMSTRINGS.
- QUADRUPTED POSITION: ASK THE PATIENT TO RIDE YOUR KNEES PLAY 'HORSY' AND SLOWLY MOVE YOUR KNEES TO AND FRO AND SIDEWAYS SO THAT TO SHIFT WEIGHT FROM SIDE TO SIDE.
- WALL LEG LIFTS IN STANDING STAND WITH YOUR SIDE FACING A WALL. LIFT YOUR LEG OUT TO THE SIDE AS HIGH AS POSSIBLE. LOWER AND REPEAT WITH THE OTHER LEG. TARGETS HIP ABDUCTERS
- KNEELING
- VERTICLE LIFT
- Squats
Conventional physical therapy groupProcedure or surgery
CONVENTIONAL PHYSICAL THERAPY CONVENTIONAL PHYSICAL THERAPY Week 1 Orientation of exercises Week 2-3 UPPER LIMB (20 MINS) Lifting a glass of water with elbow extended Moving objects from the table to a box Combing Hairs LOWER LIMB (20 MINS) Lifting the lower extremity and lowering in o nto a footstool sit to stand Standing up with loaded trey in hand corner hamstring stretch butterfly stretch Week 4-5 UPPER LIMB (20 MINS) Grasping and releasing objects lifting a glass of water to a level of 90° shoul der flexion with an extended elbow Moving objects from the table to a box LOWER LIMB (20 MINS) Reciprocal leg flexion and extension single leg stance Kicking a ball Week 5-8 UPPER LIMB (20 MINS) Opening Jars Throwing Balls Same As previous weeks LOWER LIMB (20 MINS) Squatting
| Study group | Role | What they receive |
|---|---|---|
| calisthenic training group | Experimental | CALISTHENIC TRAINING
CALISTHENIC EXERCISES
COMMAND AND TARGET MUSCLE GROUP
1. LEG RAISES (LEG STRENGTH) LIE ON YOUR BACK WITH YOUR LEGS STRAIGHT. LIFT LEGS OFF THE GROUND IN FRONT. LOWER THEM BACK DOWN WITHOUT TOUCHING THE FLOOR.
TARGETS HIP FLEXOR
2. SIDE LEG RAISES (LEG STRENGTH) LIE ON YOUR BACK WITH YOUR LEGS STRAIGHT. LIFT LEGS OFF THE GROUND AND TAKE IT TO SIDE MAXIMALL WITHOUT TOUCHING THE FLOOR.
TARGETS LOWER ABS AND HIP ABDUCTORS
3. GLUTE BRIDGES ( BACK STRENGTH) LIE ON YOUR BACK WITH YOUR KNEES BENT. LIFT YOUR HIPS OFF THE GROUND, SQUEEZING YOUR GLUTES. LOWER AND REPEAT. TARGETS GLUTES AND HAMSTRINGS.
4. QUADRUPTED POSITION:
ASK THE PATIENT TO RIDE YOUR KNEES PLAY 'HORSY' AND SLOWLY MOVE YOUR KNEES TO AND FRO AND SIDEWAYS SO THAT TO SHIFT WEIGHT FROM SIDE TO SIDE.
5. WALL LEG LIFTS
6. KNEELING
7. Vertical Lift
8. Squats Receives: Procedure: calisthenic training |
| conventional physical therapy group | Experimental | CONVENTIONAL PHYSICAL THERAPY
CONVENTIONAL PHYSICAL THERAPY Week 1 Orientation of exercises Week 2-3 UPPER LIMB (20 MINS)
Lifting a glass of water with elbow extended Moving objects from the table to a box Combing Hairs LOWER LIMB (20 MINS) Lifting the lower extremity and lowering in o nto a footstool sit to stand Standing up with loaded trey in hand corner hamstring stretch butterfly stretch Week 4-5 UPPER LIMB (20 MINS) Grasping and releasing objects lifting a glass of water to a level of 90° shoul der flexion with an extended elbow Moving objects from the table to a box LOWER LIMB (20 MINS) Reciprocal leg flexion and extension single leg stance Kicking a ball
Week 5-8 UPPER LIMB (20 MINS) Opening Jars Throwing Balls Same As previous weeks LOWER LIMB (20 MINS) Squatting Receives: Procedure: Conventional physical therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
mobility
The WeeFIM was used, it is an 18-item, 7-level ordinal scale. Each item is scored on a 7-level scale, with the total score ranging from 18 (lowest) to 126 (highest).
Measured: 8 weeks
Activities of Daily Living Performance
Will be measured by weefim functional independence measure scale. It is an 18-item, 7-level ordinal scale.
Each item is scored on a 7-level scale, with the total score ranging from 18 (lowest) to 126 (highest).
Measured: 8 weeks
Secondary outcomes (1)
Postural control
Will be assessed by paediatric assessment scale It has 14 items and 5 level scale.1 indicating complete dependence and 5 indicating complete independence total score are 56.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start12 Sep 2024
- Primary completion2 May 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Activities of Daily LivingStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966076
- Sponsor's protocol ID
- FUI/CTR/2024/70
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Callisthenic Training on Mobility and ADL Performance in Spastic Diplegic Cerebral Palsy Patients
- ClinicalTrials.gov ID
- NCT06966076
- Acronym / sponsor ID
- FUI/CTR/2024/70
- Conditions
- Activities of Daily Living, Postural Control, Spasticity, Mobility
- Keywords
- calisthenic training, postural control, conventional PT, FES-I, dynamic gait index, TUG, berg balance scale, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 11 May 2025 (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.
Almost 2 to 3 out of every 1000 children have Cerebral palsy in Pakistan.Spastic type of CP is dominant about 75%, diplegia (40%) and hemiplegic are (35.5%).Spastic diplegics have tightness of lower limb more than upper limb.Their chief complaints are reduced mobility,impaired balance and coordination and lack of postural control and stability.Calisthenic training is sort of strengthening exercises in which patient use his/her own body weight as a resistance.
Calisthenic training aims to reduce movement limitation,contracture formation and improves patient's mobility for daily transfers and ambulation,active participation of patient in indoor and outdoor activities and enhance postural stability and controle during routine tasks. The current study aims to determine the effects of calisthenic training on mobility and ADL performance in spastic diplegic cerebral palsy children aged 5-12 years fulfilling the GMFCS criteria levels 1-3. A randomized control trial will be conducted in multidisciplinary lab of FUCP, department of physical medicine and peads and rehabilitation of Fauji Foundation Hospital on the sample of 32 participants. The subjects will be randomized into two groups by sealed opaque envelope method. Baseline assessment would be done by using WEEFIM measurement assessment scale for mobility and ADL performance, pediatric balance assessment Scale for postural control. Data will be collected at baseline before intervention, after 3 weeks and finally after 6 weeks of intervention. Interventional group will be receiving calisthenic training and conventional physical therapy while control group will be receiving conventional physical therapy alone. Exercise training would be done for a total of 12 sessions for 6 weeks, twice a week with each session lasting 45 minutes. Analysis would be done by using SPSS version 21. Ethical approval will be obtained from ERC of FUSH. Informed written consent will be obtained from all participants.
Detailed description
OBJECTIVES OF STUDY
- To determine the affects of callisthenic exercises in comparison to conventional physical therapy on mobility, ADL perfrmance and quality of life in spastic diplegic cp children .
- To determine the affects of callisthenic exercises in comparison to conventional physical therapy on postural controle in spastic diplegic cp
HYPOTHESIS:
Alternate hypothesis:
- affect of calisthenic training in comparison to conventional physical therapy on mobility in spastic diplegic cp patients (p<0.05).
- 2HA- There will be statistically significant difference in the affect of calisthenic training in comparison to conventional physical therapy to improve ADL performance in spastic diplegic cp patients (p<0.05).
- 3HA- There will be statistically significant difference in the effect of calisthenic training in comparison to conventional physical therapy to improve postural controle in spastic diplegic cp patients (p<0.05).
NULL HYPOTHESIS
- 1H0 -There will be no statistically significant difference in the effect of calisthenic training in comparison to conventional physical therapy to improve ADL performance in spastic diplegic cp patients (p<0.05).
- 2H0 -There will be no statistically significant difference in the effect of calisthenic training in comparison to conventional physical therapy to improve mobility in spastic diplegic cp patients (p<0.05). 3H0 -There will be no statistically significant difference in the effect of calisthenic trainingin comparison to conventional physical therapy to improve postural controle in spastic diplegic cp patients (p<0.05).
Significanve of study:
As there is no any Conclusive evidence of calisthenic training more precisely for spastic diplegic cp children so this study will be helpful for patients and other health care proffessionals to implement this study in their clinical practice and for the patients in a way they can keep continue this treatment protocol in their home bound friendly environment by using their own body weights as a resistance after quiting from sessions of this research .
it will provide a treatment protocol for targeting calisthenic training to improve mobility, incorporate postural corrections and functional capacitance in spastic cp children .
This study will maximize the indoor functional independency in the cerebral palsy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calisthenic training group | Experimental | Procedure: calisthenic trainingCALISTHENIC TRAINING CALISTHENIC EXERCISES COMMAND AND TARGET MUSCLE GROUP 1. LEG RAISES (LEG STRENGTH) LIE ON YOUR BACK WITH YOUR LEGS STRAIGHT. LIFT LEGS OFF THE GROUND IN FRONT. LOWER THEM BACK DOWN WITHOUT TOUCHING THE FLOOR. TARGETS HIP FLEXOR 2. SIDE LEG RAISES (LEG STRENGTH) LIE ON YOUR BACK WITH YOUR LEGS STRAIGHT. LIFT LEGS OFF THE GROUND AND TAKE IT TO SIDE MAXIMALL WITHOUT TOUCHING THE FLOOR. TARGETS LOWER ABS AND HIP ABDUCTORS 3. GLUTE BRIDGES ( BACK STRENGTH) LIE ON YOUR BACK WITH YOUR KNEES BENT. LIFT YOUR HIPS OFF THE GROUND, SQUEEZING YOUR GLUTES. LOWER AND REPEAT. TARGETS GLUTES AND HAMSTRINGS. 4. QUADRUPTED POSITION: ASK THE PATIENT TO RIDE YOUR KNEES PLAY 'HORSY' AND SLOWLY MOVE YOUR KNEES TO AND FRO AND SIDEWAYS SO THAT TO SHIFT WEIGHT FROM SIDE TO SIDE. 5. WALL LEG LIFTS 6. KNEELING 7. Vertical Lift 8. Squats |
| conventional physical therapy group | Experimental | Procedure: Conventional physical therapy groupCONVENTIONAL PHYSICAL THERAPY CONVENTIONAL PHYSICAL THERAPY Week 1 Orientation of exercises Week 2-3 UPPER LIMB (20 MINS) Lifting a glass of water with elbow extended Moving objects from the table to a box Combing Hairs LOWER LIMB (20 MINS) Lifting the lower extremity and lowering in o nto a footstool sit to stand Standing up with loaded trey in hand corner hamstring stretch butterfly stretch Week 4-5 UPPER LIMB (20 MINS) Grasping and releasing objects lifting a glass of water to a level of 90° shoul der flexion with an extended elbow Moving objects from the table to a box LOWER LIMB (20 MINS) Reciprocal leg flexion and extension single leg stance Kicking a ball Week 5-8 UPPER LIMB (20 MINS) Opening Jars Throwing Balls Same As previous weeks LOWER LIMB (20 MINS) Squatting |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 5 and 13 years
- Able to accept and follow verbal instructions
- Able to participate in a training program
- Based on Gross Motor Function Classification System (GMFCS SCALE 1,2 and 3)
Key exclusion criteria (2 listed)
- If they have controlled seizures
- If they suffered from any inflammatory, infectious diseases, cognitive deficiencies and any musculoskeletal deformity with chronic contracture that interfere with physical activity.
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 |
|---|---|---|
| calisthenic trainingCOMMAND AND TARGET MUSCLE GROUP 1. LEG RAISES (LEG STRENGTH) LIE ON YOUR BACK WITH YOUR LEGS STRAIGHT. LIFT LEGS OFF THE GROUND IN FRONT. LOWER THEM BACK DOWN WITHOUT TOUCHING THE FLOOR. TARGETS HIP FLEXOR 2. SIDE LEG RAISES (LEG STRENGTH) LIE ON YOUR BACK WITH YOUR LEGS STRAIGHT. LIFT LEGS OFF THE GROUND AND TAKE IT TO SIDE MAXIMALL WITHOUT TOUCHING THE FLOOR. TARGETS LOWER ABS AND HIP ABDUCTORS 3. GLUTE BRIDGES ( BACK STRENGTH) LIE ON YOUR BACK WITH YOUR KNEES BENT. LIFT YOUR HIPS OFF THE GROUND, SQUEEZING YOUR GLUTES. LOWER AND REPEAT. TARGETS GLUTES AND HAMSTRINGS. 4. QUADRUPTED POSITION: ASK THE PATIENT TO RIDE YOUR KNEES PLAY 'HORSY' AND SLOWLY MOVE YOUR KNEES TO AND FRO AND SIDEWAYS SO THAT TO SHIFT WEIGHT FROM SIDE TO SIDE. 5. WALL LEG LIFTS IN STANDING STAND WITH YOUR SIDE FACING A WALL. LIFT YOUR LEG OUT TO THE SIDE AS HIGH AS POSSIBLE. LOWER AND REPEAT WITH THE OTHER LEG. TARGETS HIP ABDUCTERS 6. KNEELING 7. VERTICLE LIFT 8. Squats | Procedure or surgery | calisthenic training group |
| Conventional physical therapy groupCONVENTIONAL PHYSICAL THERAPY CONVENTIONAL PHYSICAL THERAPY Week 1 Orientation of exercises Week 2-3 UPPER LIMB (20 MINS) Lifting a glass of water with elbow extended Moving objects from the table to a box Combing Hairs LOWER LIMB (20 MINS) Lifting the lower extremity and lowering in o nto a footstool sit to stand Standing up with loaded trey in hand corner hamstring stretch butterfly stretch Week 4-5 UPPER LIMB (20 MINS) Grasping and releasing objects lifting a glass of water to a level of 90° shoul der flexion with an extended elbow Moving objects from the table to a box LOWER LIMB (20 MINS) Reciprocal leg flexion and extension single leg stance Kicking a ball Week 5-8 UPPER LIMB (20 MINS) Opening Jars Throwing Balls Same As previous weeks LOWER LIMB (20 MINS) Squatting | Procedure or surgery | conventional physical therapy group |
Primary outcome
mobility
Time frame: 8 weeks
The WeeFIM was used, it is an 18-item, 7-level ordinal scale. Each item is scored on a 7-level scale, with the total score ranging from 18 (lowest) to 126 (highest).
Activities of Daily Living Performance
Time frame: 8 weeks
Will be measured by weefim functional independence measure scale. It is an 18-item, 7-level ordinal scale. Each item is scored on a 7-level scale, with the total score ranging from 18 (lowest) to 126 (highest).
1 secondary outcome
Postural control
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calisthenic training and Conventional physical therapy group in people with Activities of Daily Living and Postural Control, run by Foundation University Islamabad 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 15 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mobility (time frame: 8 weeks). The study lists 2 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 15 May 2025.