Cerebral Palsy (CP)BWSTT DCPNCT07263542
Effects of Body Weight Supported Treadmill Training on Motor Development in Patients With Dyskinetic Cerebral Palsy
A study testing BODY WEIGHT SUPPORTED TREADMILL TRAINING and BOBATH THERAPY in people with Cerebral Palsy (CP), run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
Trial summary
This randomized controlled trial will evaluate motor development outcomes in children aged 5-12 years with dyskinetic cerebral palsy. The Primary Outcome measures will be Gross motor development, gait, trunk control, balance, and coordination, and will be assessed using the Shoaib Sensorimotor Development Tool (SMDT)… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- BODY WEIGHT SUPPORTED TREADMILL TRAINING and BOBATH THERAPY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Dec 2025to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- This study will include DCP Patients aged 5-12 years without any gender preference, falling at GMFCS levels I-II. The included participants must be capable of following instructions and must not have any known surgical or medical history.
Who cannot join
- DCP patients having cardiac complications, Past surgical history, Mental retardation, visual and cognitive deficits, under another gait training protocol, Congenital musculoskeletal defects, dislocations of the hip, significant hip and knee contractures, Behavioral disorders, or a history of Recent botulinum toxin injections, or uncontrolled epilepsy will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
University of Biological and Applied Sciences
Lahore, Punjab Province, 53,200
About this study
Official title: Effects of Body Weight Supported Treadmill Training on Motor Development in Patients Withh Dyskinetic Cerebral Palsy
This randomized controlled trial will evaluate motor development outcomes in children aged 5-12 years with dyskinetic cerebral palsy. The Primary Outcome measures will be Gross motor development, gait, trunk control, balance, and coordination, and will be assessed using the Shoaib Sensorimotor Development Tool (SMDT), Gross Motor Function Measure-88 (GMFM-88), Jacks' observational Gait Analysis scale, Trunk Impairment Scale (TIS), Time Up and Go Test, and Heel-to-Shin test. The fine motor development as a secondary outcome measure will be assessed using the Box and Block Test (BBT). Before allocating participants within the study, informed consent will be obtained to ensure rigorous adherence to the Principles of Ethical Research as outlined in the Helsinki Declaration for Ethical Research. Baseline readings will be recorded using the selected tools against the pre-defined outcome measures. Randomization will be done through an online tool, and the Participants will be divided into two intervention arms. The control group will receive conventional Bobath therapy, and the experimental group will undergo body weight-supported treadmill training (BWSTT), with both interventions administered over a period of 4 weeks, 5 days a week. Each session will be structured as follows: 5 minutes of warm-up exercises to prepare the body, followed by a 30-minute core treatment session focused on therapeutic interventions, concluding with 5 minutes of cooldown exercises to promote recovery and relaxation. This sequence ensures a balanced approach while maintaining the total session duration of 40 minutes, 5 days a week for 4 weeks. Statistical analysis of the results will be conducted using SPSS software to determine the significance of the findings. The Shapiro-Wilk test will be employed to determine the normality of the data. If the data distribution is normal, an independent t-test will be employed for between-group comparison; otherwise, non-parametric alternatives will be applied. Within group analysis, a paired t-test will be applied to evaluate differences and the results will be reported.
Read the detailed description
The interventions to both groups will be applied for 40 minutes, 5 days a week, for 4 weeks. 5 minutes of warm-up and cool-down exercises will be administered to both groups before and after the administration of interventions. Subsequently, participants will receive 30 minutes of treatment according to the pre-designed protocol.
- Group A, or the experimental group, will receive BWSTT with 40% weight offloading and a treadmill speed of 0.4 miles per hour (mph) at the start of the treatment.
- Weight offloading will be progressively decreased by 10% each week, leading to 30% offloading in the 2nd week, with the treadmill speed adjusting to 0.8 mph
- 20% offloading in the 3rd week, with speed increasing to 1.2 mph; and 10% offloading during the 4th week of the intervention at a speed of 1.6 mph, for 30 minutes a day, five days a week for four weeks. 40-minute BWSTT treatment sessions will have 8 minutes of exercise intervals followed by 2-minute rest intervals (16).
In contrast, GROUP-B or the control group will be given Bobath therapy.
- This will include dynamic balance training on a balance board for 6 minutes, followed by a 2-minute rest.
- functional reaching, and ball-throwing exercises for 6 minutes, followed by a 2-minute rest period.
- Supine pelvic bridging exercises for 6 minutes, followed by a 2-minute rest interval.
- weight-bearing exercises in sitting, standing, kneeling, and crawling positions to facilitate equal body weight transfers without disturbing postural control for another six minutes, followed by two minutes of rest.
- Obstacle negotiation (cones, steps) with focus on: Heel-strike initiation, Stance-phase knee control, and Push-off symmetry for six minutes.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- BODY WEIGHT SUPPORTED TREADMILL TRAINING, BOBATH THERAPY
- Keywords
- cerebral palsy, BWSTT, DCP, RCT
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BODY WEIGHT SUPPORTED TREADMILL TRAININGOther
The experimental group, will receive BWSTT with 40% weight offloading and a treadmill speed of 0.4 miles per hour (mph) at the start of the treatment. Weight offloading will be progressively decreased by 10% each week, leading to 30% offloading in the 2nd week, with the treadmill speed adjusting to 0.8 mph, 20% offloading in the 3rd week, with speed increasing to 1.2 mph; and 10% offloading during the 4th week of the intervention at a speed of 1.6 mph, for 30 minutes a day, five days a week for four weeks.
BOBATH THERAPYOther
The control group, will receive Bobath Therapy. The protocol will include dynamic balance training on a balance board for 6 minutes, followed by a 2-minute rest. Functional reaching and ball-throwing exercises for 6 minutes, followed by a 2-minute rest period. Supine pelvic bridging exercises for 6 minutes, followed by 2-minute rest intervals. weight-bearing exercises in sitting, standing, kneeling, and crawling positions to facilitate equal body weight transfers without disturbing postural control for another six minutes, followed by a 2-minute rest. Obstacle negotiation (cones, steps) with focus on: Heel-strike initiation, Stance-phase knee control, and Push-off symmetry for six minutes.
| Study group | Role | What they receive |
|---|---|---|
| BWSTT | Experimental | Experimental group will recieve body weight supported treadmill training. Receives: Other: BODY WEIGHT SUPPORTED TREADMILL TRAINING |
| BOBATH | Active comparator | comparator group will recieve Bobath therapy Receives: Other: BOBATH THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross motor Development
Gross Motor Development will be analyzed using GMFM-88. The tool categorizes motor development into five domains: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. These domains encompass 88 items, each scored on a 4-point ordinal scale ranging from 0 (indicating the inability to initiate the movement) to 3 (representing task completion). Higher scores reflect greater motor development in the patient.
Measured: 4 weeks
Gross motor Development
Gross Motor Development will be analyzed using the Shoaib sensorimotor Development Tool. The standardized protocol comprises 72 developmentally stratified items employing a tripartite scoring matrix (0, 0.5, 1). The maximum attainable score is 72, while a score below 36 predicts atypical development.
Measured: 4 weeks
Gait analysis
Gait analysis will be conducted using Jacks' Observational Gait Analysis. It is a qualitative assessment instrument designed for the systematic identification of pathokinematic deviations from normal gait patterns across the entire cycle. Instead of employing an ordinal quantification system, it employs a comparative observational framework where abnormalities are evaluated against established normative biomechanical parameters.
Measured: 4 week
trunk control
Trunk Control assessment will be done using Trunk Impairment Scale. It assesses trunk control in three key domains: static sitting balance (ability to maintain upright posture), dynamic sitting balance (weight-shifting and reaching), and coordination (rotational movements). Scoring ranges from 0 (severe impairment) to 23 (normal function), providing quantitative data for rehabilitation progress tracking
Measured: 4 weeks
Dynamic Balance and functional mobility
The balance will be assessed using Time up and Go Test. Key metrics measured are the time taken to stand, walk, turn, and sit. Normal score falls between 10-12 seconds. The greater the time required to accomplish the task, the greater the gravity of the problem.
Measured: 4 weeks
motor coordination assessment
Motor coordination assessment will be conducted through the standardized heel-shin coordination test to evaluate volitional limb control precision. Participants will be instructed to perform the maneuver in supine position by sliding the plantar aspect of one foot along the contralateral tibial crest, maintaining continuous contact from the tibial tuberosity to the lateral malleolus. The quality of the movement will be indicative of coordinated limb function. Jerky or clumsy movement and failure to perform it throughout the dictated range are indicative of neurological pathology.
Measured: 4 weeks
Secondary outcomes (1)
Fine Motor Development
Fine Motor Development will be assessed through the Box and Block Test by counting the number of small blocks a person can move from one side of a partitioned box to the other in 60 seconds. A higher score indicates greater dexterity, while a lower score may suggest impairment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion10 Apr 2026 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Lahore University of Biological and Applied SciencesThe 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
- Model description
- The study utilizes parallel study design in which two groups will receive two different interventions. This design allows the comparison of two different treatment approaches under identical conditions.2
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Shoaib Waqas, Lahore University of Biological and Applied Sciences
- Investigators
- Hafsa Jamil, DPT, Principal investigator, Lahore University of Biological and Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263542
- Sponsor's protocol ID
- UBS24LMSPT011
- Acronym
- BWSTT DCP
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data (IDP) will not be disclosed to preserve patient confidentiality and comply with privacy protection protocols. Sharing raw datasets carries inherent risks, including potential misinterpretation of sensitive health information and unauthorized utilization by third parties, which could lead to non-consensual exploitation or breaches of ethical guidelines. To mitigate these concerns, aggregated or anonymized data will be provided in alignment with regulatory standards for transparency while safeguarding participant identities.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Body Weight Supported Treadmill Training on Motor Development in Patients Withh Dyskinetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07263542
- Acronym / sponsor ID
- BWSTT DCP / UBS24LMSPT011
- Conditions
- Cerebral Palsy (CP)
- Keywords
- cerebral palsy, BWSTT, DCP, RCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 4 Dec 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.
This randomized controlled trial will evaluate motor development outcomes in children aged 5-12 years with dyskinetic cerebral palsy. The Primary Outcome measures will be Gross motor development, gait, trunk control, balance, and coordination, and will be assessed using the Shoaib Sensorimotor Development Tool (SMDT), Gross Motor Function Measure-88 (GMFM-88), Jacks' observational Gait Analysis scale, Trunk Impairment Scale (TIS), Time Up and Go Test, and Heel-to-Shin test. The fine motor development as a secondary outcome measure will be assessed using the Box and Block Test (BBT). Before allocating participants within the study, informed consent will be obtained to ensure rigorous adherence to the Principles of Ethical Research as outlined in the Helsinki Declaration for Ethical Research. Baseline readings will be recorded using the selected tools against the pre-defined outcome measures. Randomization will be done through an online tool, and the Participants will be divided into two intervention arms. The control group will receive conventional Bobath therapy, and the experimental group will undergo body weight-supported treadmill training (BWSTT), with both interventions administered over a period of 4 weeks, 5 days a week. Each session will be structured as follows: 5 minutes of warm-up exercises to prepare the body, followed by a 30-minute core treatment session focused on therapeutic interventions, concluding with 5 minutes of cooldown exercises to promote recovery and relaxation. This sequence ensures a balanced approach while maintaining the total session duration of 40 minutes, 5 days a week for 4 weeks. Statistical analysis of the results will be conducted using SPSS software to determine the significance of the findings. The Shapiro-Wilk test will be employed to determine the normality of the data. If the data distribution is normal, an independent t-test will be employed for between-group comparison; otherwise, non-parametric alternatives will be applied. Within group analysis, a paired t-test will be applied to evaluate differences and the results will be reported.
Detailed description
The interventions to both groups will be applied for 40 minutes, 5 days a week, for 4 weeks. 5 minutes of warm-up and cool-down exercises will be administered to both groups before and after the administration of interventions. Subsequently, participants will receive 30 minutes of treatment according to the pre-designed protocol.
- Group A, or the experimental group, will receive BWSTT with 40% weight offloading and a treadmill speed of 0.4 miles per hour (mph) at the start of the treatment.
- Weight offloading will be progressively decreased by 10% each week, leading to 30% offloading in the 2nd week, with the treadmill speed adjusting to 0.8 mph
- 20% offloading in the 3rd week, with speed increasing to 1.2 mph; and 10% offloading during the 4th week of the intervention at a speed of 1.6 mph, for 30 minutes a day, five days a week for four weeks. 40-minute BWSTT treatment sessions will have 8 minutes of exercise intervals followed by 2-minute rest intervals (16).
In contrast, GROUP-B or the control group will be given Bobath therapy.
- This will include dynamic balance training on a balance board for 6 minutes, followed by a 2-minute rest.
- functional reaching, and ball-throwing exercises for 6 minutes, followed by a 2-minute rest period.
- Supine pelvic bridging exercises for 6 minutes, followed by a 2-minute rest interval.
- weight-bearing exercises in sitting, standing, kneeling, and crawling positions to facilitate equal body weight transfers without disturbing postural control for another six minutes, followed by two minutes of rest.
- Obstacle negotiation (cones, steps) with focus on: Heel-strike initiation, Stance-phase knee control, and Push-off symmetry for six minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study utilizes parallel study design in which two groups will receive two different interventions. This design allows the comparison of two different treatment approaches under identical conditions.2
| Arm | Type | Receives |
|---|---|---|
| BWSTT | Experimental | Other: BODY WEIGHT SUPPORTED TREADMILL TRAININGExperimental group will recieve body weight supported treadmill training. |
| BOBATH | Active comparator | Other: BOBATH THERAPYcomparator group will recieve Bobath therapy |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- This study will include DCP Patients aged 5-12 years without any gender preference, falling at GMFCS levels I-II. The included participants must be capable of following instructions and must not have any known surgical or medical history.
Key exclusion criteria (1 listed)
- DCP patients having cardiac complications, Past surgical history, Mental retardation, visual and cognitive deficits, under another gait training protocol, Congenital musculoskeletal defects, dislocations of the hip, significant hip and knee contractures, Behavioral disorders, or a history of Recent botulinum toxin injections, or uncontrolled epilepsy will be excluded from the study.
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 |
|---|---|---|
| BODY WEIGHT SUPPORTED TREADMILL TRAININGThe experimental group, will receive BWSTT with 40% weight offloading and a treadmill speed of 0.4 miles per hour (mph) at the start of the treatment. Weight offloading will be progressively decreased by 10% each week, leading to 30% offloading in the 2nd week, with the treadmill speed adjusting to 0.8 mph, 20% offloading in the 3rd week, with speed increasing to 1.2 mph; and 10% offloading during the 4th week of the intervention at a speed of 1.6 mph, for 30 minutes a day, five days a week for four weeks. | Other | BWSTT |
| BOBATH THERAPYThe control group, will receive Bobath Therapy. The protocol will include dynamic balance training on a balance board for 6 minutes, followed by a 2-minute rest. Functional reaching and ball-throwing exercises for 6 minutes, followed by a 2-minute rest period. Supine pelvic bridging exercises for 6 minutes, followed by 2-minute rest intervals. weight-bearing exercises in sitting, standing, kneeling, and crawling positions to facilitate equal body weight transfers without disturbing postural control for another six minutes, followed by a 2-minute rest. Obstacle negotiation (cones, steps) with focus on: Heel-strike initiation, Stance-phase knee control, and Push-off symmetry for six minutes. | Other | BOBATH |
Primary outcome
Gross motor Development
Time frame: 4 weeks
Gross Motor Development will be analyzed using GMFM-88. The tool categorizes motor development into five domains: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. These domains encompass 88 items, each scored on a 4-point ordinal scale ranging from 0 (indicating the inability to initiate the movement) to 3 (representing task completion). Higher scores reflect greater motor development in the patient.
Gross motor Development
Time frame: 4 weeks
Gross Motor Development will be analyzed using the Shoaib sensorimotor Development Tool. The standardized protocol comprises 72 developmentally stratified items employing a tripartite scoring matrix (0, 0.5, 1). The maximum attainable score is 72, while a score below 36 predicts atypical development.
Gait analysis
Time frame: 4 week
Gait analysis will be conducted using Jacks' Observational Gait Analysis. It is a qualitative assessment instrument designed for the systematic identification of pathokinematic deviations from normal gait patterns across the entire cycle. Instead of employing an ordinal quantification system, it employs a comparative observational framework where abnormalities are evaluated against established normative biomechanical parameters.
trunk control
Time frame: 4 weeks
Trunk Control assessment will be done using Trunk Impairment Scale. It assesses trunk control in three key domains: static sitting balance (ability to maintain upright posture), dynamic sitting balance (weight-shifting and reaching), and coordination (rotational movements). Scoring ranges from 0 (severe impairment) to 23 (normal function), providing quantitative data for rehabilitation progress tracking
Dynamic Balance and functional mobility
Time frame: 4 weeks
The balance will be assessed using Time up and Go Test. Key metrics measured are the time taken to stand, walk, turn, and sit. Normal score falls between 10-12 seconds. The greater the time required to accomplish the task, the greater the gravity of the problem.
motor coordination assessment
Time frame: 4 weeks
Motor coordination assessment will be conducted through the standardized heel-shin coordination test to evaluate volitional limb control precision. Participants will be instructed to perform the maneuver in supine position by sliding the plantar aspect of one foot along the contralateral tibial crest, maintaining continuous contact from the tibial tuberosity to the lateral malleolus. The quality of the movement will be indicative of coordinated limb function. Jerky or clumsy movement and failure to perform it throughout the dictated range are indicative of neurological pathology.
1 secondary outcome
Fine Motor Development
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No. Individual patient data (IDP) will not be disclosed to preserve patient confidentiality and comply with privacy protection protocols. Sharing raw datasets carries inherent risks, including potential misinterpretation of sensitive health information and unauthorized utilization by third parties, which could lead to non-consensual exploitation or breaches of ethical guidelines. To mitigate these concerns, aggregated or anonymized data will be provided in alignment with regulatory standards for transparency while safeguarding participant identities.
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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.
Hafsa Jamil, DPT principal investigator
Lahore University of Biological and Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BODY WEIGHT SUPPORTED TREADMILL TRAINING and BOBATH THERAPY in people with Cerebral Palsy (CP), run by Lahore University of Biological and Applied Sciences 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 4 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaoib Waqas, P.hd (+923024552109, shoaib.waqas@ubas.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross motor Development (time frame: 4 weeks). The study lists 6 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 4 Dec 2025.