Spastic Diplegic Cerebral PalsyNCT07829796
Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Gait and Self-Esteem in Children With Spastic Cerebral Palsy
A study testing Active Transcranial Direct Current Stimulation, Virtual Reality Rehabilitation and Conventional Physical Therapy in people with Spastic Diplegic Cerebral Palsy, run by Riphah International University at 2 sites in Pakistan.
Trial summary
Cerebral palsy can affect walking ability, muscle control, functional mobility, and psychosocial well-being in children. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may support motor learning, while virtual reality (VR) rehabilitation provides interactive… Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Spastic Diplegic Cerebral Palsy
- What is being tested?
- Active Transcranial Direct Current Stimulation, Virtual Reality Rehabilitation and Conventional Physical Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Sep 2026to 28 Oct 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with spastic cerebral palsy (spastic diplegia). Age 8-16 years. Gross Motor Function Classification System (GMFCS) levels I-III. Presence of mild to moderate lower-limb spasticity, defined as a Modified Tardieu Scale (MTS) score between 1 and 3 in at least one major lower-limb muscle group, such as the gastrocnemius, hamstrings, or hip adductors.
- Able to understand and follow verbal instructions. Parent or guardian provides informed consent and the child provides assent.
Who cannot join
- History of seizures or epilepsy. Implanted metal or electronic devices, such as a pacemaker. Severe cognitive impairment that prevents comprehension of study tasks. Skin allergies, lesions, or other conditions affecting the electrode application sites.
- Current use of antispasticity medication that could directly influence spasticity outcomes.
- Botulinum toxin injection within the previous 3 months. Recent orthopedic surgery or change in medication regimen within the previous 5 days.
- Concurrent participation in alternative or adjunct therapies outside the study protocol.
- Refusal to participate or withdrawal of consent/assent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Al-Farabi Special Education Centre for Physically Handicapped
Islamabad, 44000
hassan rauf, MS PEDIATRIC PHYSICAL THERAPY, +923161504297, hassanrauf507@gmail.com
- Recruiting
Sedum School of Rehabilitation
Islamabad, 44000
hassan rauf, MS PEDIATRIC PHYSICAL THERAPY, +923161504297, hassanrauf507@gmail.com
About this study
Official title: Effects of Transcranial Direct Current Stimulation in Addition to Virtual Reality on Gait and Self-Esteem in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
Cerebral palsy can affect walking ability, muscle control, functional mobility, and psychosocial well-being in children. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may support motor learning, while virtual reality (VR) rehabilitation provides interactive, repetitive, and task-specific motor training.
This randomized controlled trial will investigate whether active tDCS combined with VR rehabilitation provides additional benefits compared with sham tDCS combined with the same VR rehabilitation and conventional physical therapy in children with spastic cerebral palsy.
Read more
A total of 42 children aged 8 to 16 years with spastic diplegic cerebral palsy and Gross Motor Function Classification System (GMFCS) levels I-III will be randomly assigned in a 1:1:1 ratio to one of three groups: active tDCS plus VR, sham tDCS plus VR, or conventional physical therapy. Each group will receive 18 treatment sessions over six weeks, with three sessions per week.
Outcomes will be assessed before treatment, after nine sessions, and after 18 sessions. The primary outcomes will be gait performance measured using the 10-Meter Walk Test and self-esteem measured using the Rosenberg Self-Esteem Scale. Secondary outcomes will evaluate spasticity, gross motor function, functional mobility, and functional independence.
Read the detailed description
This study is a three-arm, parallel-group, randomized controlled trial designed to evaluate the effects of active transcranial direct current stimulation (tDCS) combined with virtual reality (VR) rehabilitation in children with spastic cerebral palsy. The study will compare active tDCS plus VR with sham tDCS plus an identical VR protocol and with conventional physical therapy.
Forty-two children with spastic diplegic cerebral palsy, aged 8-16 years and classified within Gross Motor Function Classification System (GMFCS) levels I-III, will be enrolled. Eligible participants will be randomly allocated in a 1:1:1 ratio, with 14 participants assigned to each treatment group. Outcome assessment will be performed by an assessor blinded to treatment allocation.
Participants in all three groups will complete 18 treatment sessions over six weeks at a frequency of three sessions per week. The active tDCS plus VR group will receive low-intensity tDCS at 1 mA for 20 minutes per session in combination with a structured VR-based rehabilitation programme. The VR programme will include progressively challenging activities directed toward postural control, balance, coordination, gait-related activity, and cognitive-motor integration.
Participants in the sham tDCS plus VR group will undergo the same electrode setup and VR rehabilitation programme. Sham stimulation will be delivered briefly at the beginning of the session to reproduce the initial sensations of stimulation without providing continued active cortical stimulation. Participants allocated to conventional physical therapy will receive a structured rehabilitation programme incorporating stretching, lower-limb strengthening, balance training, gait training, functional mobility exercises, and progressive task-specific practice.
Assessments will be conducted at baseline before the intervention (S0), after nine treatment sessions at the midpoint of the programme (S9), and following completion of 18 treatment sessions (S18).
The co-primary outcomes will be gait performance, assessed using the 10-Meter Walk Test, and self-esteem, assessed using the child version of the Rosenberg Self-Esteem Scale. Secondary outcome domains will include spasticity assessed using the Modified Tardieu Scale, gross motor function assessed using the Gross Motor Function Measure-88, functional mobility assessed using the Functional Mobility Scale, and functional independence assessed using the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT).
The study is intended to determine whether active tDCS provides an additional therapeutic effect when combined with VR rehabilitation beyond the effects associated with VR training and sham stimulation, while also comparing the technology-assisted intervention with conventional physical therapy.
- Conditions
- Spastic Diplegic Cerebral Palsy
- Being tested
- Active Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation, Virtual Reality Rehabilitation, Conventional Physical Therapy
- Keywords
- Spastic Cerebral Palsy, Spastic Diplegia, Transcranial Direct Current Stimulation, Virtual Reality, VR Rehabilitation, Walking Speed, Motor Function, Gross Motor Function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial Direct Current StimulationDevice
Also called Active tDCS
Active transcranial direct current stimulation will be delivered using saline-soaked sponge electrodes at an intensity of 1 mA for 20 minutes per session. Stimulation will be administered three times per week for six weeks, for a total of 18 sessions, concurrently with virtual reality rehabilitation. The stimulation montage will target the lower-limb motor cortical region with a supraorbital reference electrode.
Sham Transcranial Direct Current StimulationDevice
Also called Sham tDCS
Sham transcranial direct current stimulation will use the same electrode montage and setup as the active condition. Active current will be delivered only during the initial 30 seconds to reproduce the early sensory experience of stimulation, after which stimulation will be discontinued while the electrodes remain in place. Sham tDCS will be combined with the same virtual reality rehabilitation protocol as the active tDCS group.
Virtual Reality RehabilitationBehavioural
Also called Xbox Kinect-Based Virtual Reality Therapy
Virtual reality rehabilitation will be delivered using a Microsoft Xbox console with Kinect motion tracking. The program will include progressive whole-body, balance, gait-related, coordination, navigation, and dual-task activities using Kinect Adventures. Training will progress through familiarization, cognitive-motor integration, and challenge/functional integration phases over six weeks. VR will be provided in both the active and sham tDCS groups for 18 sessions.
Conventional Physical TherapyBehavioural
Also called CPT
Conventional physical therapy will be delivered for 30 minutes per session, three sessions per week for six weeks, for a total of 18 sessions. Treatment will progress from lower-limb stretching, supported balance and weight shifting to strengthening, motor-control exercises, gait initiation, overground gait training, obstacle negotiation, and functional mobility activities. Exercise difficulty and therapist support will be progressed according to participant tolerance and functional ability.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Active tDCS + Virtual Reality | Experimental | Participants will receive active transcranial direct current stimulation at 1 mA for 20 minutes combined with virtual reality rehabilitation, three sessions per week for six weeks, for a total of 18 sessions. Receives: Device: Active Transcranial Direct Current Stimulation; Behavioral: Virtual Reality Rehabilitation |
| Sham Comparator: Sham tDCS + Virtual Reality | Sham comparator | Participants will receive sham transcranial direct current stimulation using the same electrode setup, with brief initial stimulation to mimic active tDCS, combined with the same virtual reality rehabilitation protocol, three sessions per week for six weeks. Receives: Device: Sham Transcranial Direct Current Stimulation; Behavioral: Virtual Reality Rehabilitation |
| Active Comparator: Conventional Physical Therapy | Active comparator | Participants will receive conventional physical therapy including stretching, strengthening, balance training, gait training, and functional mobility exercises, three sessions per week for six weeks. Receives: Behavioral: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-Meter Walk Test Self-Selected Walking Velocity
Gait performance will be assessed using the 10-Meter Walk Test at a self-selected walking pace. Walking velocity will be expressed in meters per second (m/s), with higher values indicating faster walking performance. The measure will be collected at baseline, mid-intervention, and post-intervention.
Measured: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Child Rosenberg Self-Esteem Scale Total Score
Global self-esteem will be assessed using the Child Rosenberg Self-Esteem Scale. The scale contains 10 items and produces a total score ranging from 0 to 30, with higher scores indicating greater self-esteem. The total score will be assessed at baseline, mid-intervention, and post-intervention.
Measured: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Secondary outcomes (7)
Modified Tardieu Scale
Spasticity will be assessed using the Modified Tardieu Scale in the clinically affected lower-limb muscle groups. The assessment will include the quality of muscle reaction and the angles of muscle reaction (R1) and passive range of motion (R2). The dynamic component of spasticity will be calculated as R2 minus R1, expressed in degrees.
Measured: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
GMFM-88
Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88). The instrument evaluates five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking/running/jumping. Dimension and total scores will be expressed as percentages, with higher scores indicating better gross motor function.
Measured: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Functional Mobility Scale - 5 m, 50 m, and 500 m
Functional mobility will be assessed using the Functional Mobility Scale at 5-meter, 50-meter, and 500-meter distances, representing mobility in home, school, and community environments. Each distance is rated on a 1-to-6 scale according to the level of assistance or mobility device required, with higher scores indicating greater functional mobility.
Measured: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Pediatric Evaluation of Disability Inventory-Computer Adaptive Test Daily Activities Domain Scaled Score
Functional performance in daily activities will be assessed using the Daily Activities domain of the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT). The domain is reported as a scaled score ranging from 20 to 80. Higher scores indicate greater functional ability in daily activities and therefore a better outcome.
Measured: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Pediatric Evaluation of Disability Inventory-Computer Adaptive Test Mobility Domain Scaled Score
Functional mobility will be assessed using the Mobility domain of the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT). Scaled scores range from 20 to 80. Higher scores indicate greater mobility-related functional ability and therefore a better outcome.
Measured: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Pediatric Evaluation of Disability Inventory-Computer Adaptive Test Social/Cognitive Domain Scaled Score
Social and cognitive functional performance will be assessed using the Social/Cognitive domain of the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT). Scaled scores range from 20 to 80. Higher scores indicate greater social/cognitive functional ability and therefore a better outcome.
Measured: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Pediatric Evaluation of Disability Inventory-Computer Adaptive Test Responsibility Domain Scaled Score
Functional responsibility will be assessed using the Responsibility domain of the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT). Scaled scores range from 20 to 80. Higher scores indicate greater functional responsibility and independence and therefore a better outcome.
Measured: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start15 Sep 2026
- Primary completion28 Oct 2026 (estimated)
- Study completion28 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spastic Diplegic Cerebral PalsyStudies 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
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel intervention groups: active transcranial direct current stimulation combined with virtual reality rehabilitation, sham transcranial direct current stimulation combined with the same virtual reality rehabilitation, or conventional physical therapy. Each group will receive 18 treatment sessions over six weeks, with three sessions per week. Outcomes will be assessed at baseline, after nine sessions, and after 18 sessions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Collaborators
- IIMC, Riphah International University, Pakistan
- Responsible party
- Principal investigator, Waqar Ahmed Awan, Riphah International University
- Investigators
- WAQAR AHMED AWAN, PROFESSOR, Study chair, RIPHAH INTERNATIONAL UNIVERSITY PAKISTAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829796
- Sponsor's protocol ID
- RCRAHS-ISB/REC/MS-PT/02334
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly because the study involves a pediatric clinical population and the consent and ethical approval were not designed for unrestricted external sharing of participant-level data. Aggregate and de-identified study results will be reported in the thesis and subsequent publications.
Publications
Jung S, Song S, Lee D, Lee K, Lee G. Effects of Kinect Video Game Training on Lower Extremity Motor Function, Balance, and Gait in Adolescents with Spastic Diplegia Cerebral Palsy: A Pilot Randomized Controlled Trial. Dev Neurorehabil. 2021 Apr;24(3):159-165. doi: 10.1080/17518423.2020.1819458. Epub 2020 Sep 27.
PubMed 32981401Grecco LA, Duarte Nde A, de Mendonca ME, Pasini H, Lima VL, Franco RC, de Oliveira LV, de Carvalho Pde T, Correa JC, Collange NZ, Sampaio LM, Galli M, Fregni F, Oliveira CS. Effect of transcranial direct current stimulation combined with gait and mobility training on functionality in children with cerebral palsy: study protocol for a double-blind randomized controlled clinical trial. BMC Pediatr. 2013 Oct 11;13:168. doi: 10.1186/1471-2431-13-168.
PubMed 24112817Lazzari RD, Politti F, Belina SF, Collange Grecco LA, Santos CA, Dumont AJL, Lopes JBP, Cimolin V, Galli M, Santos Oliveira C. Effect of Transcranial Direct Current Stimulation Combined With Virtual Reality Training on Balance in Children With Cerebral Palsy: A Randomized, Controlled, Double-Blind, Clinical Trial. J Mot Behav. 2017 May-Jun;49(3):329-336. doi: 10.1080/00222895.2016.1204266. Epub 2016 Sep 20.
PubMed 27644454Collange Grecco LA, de Almeida Carvalho Duarte N, Mendonca ME, Galli M, Fregni F, Oliveira CS. Effects of anodal transcranial direct current stimulation combined with virtual reality for improving gait in children with spastic diparetic cerebral palsy: a pilot, randomized, controlled, double-blind, clinical trial. Clin Rehabil. 2015 Dec;29(12):1212-23. doi: 10.1177/0269215514566997. Epub 2015 Jan 20.
PubMed 25604912
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation in Addition to Virtual Reality on Gait and Self-Esteem in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07829796
- Acronym / sponsor ID
- RCRAHS-ISB/REC/MS-PT/02334
- Conditions
- Spastic Diplegic Cerebral Palsy
- Keywords
- Spastic Cerebral Palsy, Spastic Diplegia, Transcranial Direct Current Stimulation, Virtual Reality, VR Rehabilitation, Walking Speed, Motor Function, Gross Motor Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Collaborators
- IIMC, Riphah International University, Pakistan
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 28 Oct 2026 (estimated)
- Study completion
- 28 Oct 2026 (estimated)
- First posted
- 21 Sep 2026 (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.
Cerebral palsy can affect walking ability, muscle control, functional mobility, and psychosocial well-being in children. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may support motor learning, while virtual reality (VR) rehabilitation provides interactive, repetitive, and task-specific motor training.
This randomized controlled trial will investigate whether active tDCS combined with VR rehabilitation provides additional benefits compared with sham tDCS combined with the same VR rehabilitation and conventional physical therapy in children with spastic cerebral palsy.
A total of 42 children aged 8 to 16 years with spastic diplegic cerebral palsy and Gross Motor Function Classification System (GMFCS) levels I-III will be randomly assigned in a 1:1:1 ratio to one of three groups: active tDCS plus VR, sham tDCS plus VR, or conventional physical therapy. Each group will receive 18 treatment sessions over six weeks, with three sessions per week.
Outcomes will be assessed before treatment, after nine sessions, and after 18 sessions. The primary outcomes will be gait performance measured using the 10-Meter Walk Test and self-esteem measured using the Rosenberg Self-Esteem Scale. Secondary outcomes will evaluate spasticity, gross motor function, functional mobility, and functional independence.
Detailed description
This study is a three-arm, parallel-group, randomized controlled trial designed to evaluate the effects of active transcranial direct current stimulation (tDCS) combined with virtual reality (VR) rehabilitation in children with spastic cerebral palsy. The study will compare active tDCS plus VR with sham tDCS plus an identical VR protocol and with conventional physical therapy.
Forty-two children with spastic diplegic cerebral palsy, aged 8-16 years and classified within Gross Motor Function Classification System (GMFCS) levels I-III, will be enrolled. Eligible participants will be randomly allocated in a 1:1:1 ratio, with 14 participants assigned to each treatment group. Outcome assessment will be performed by an assessor blinded to treatment allocation.
Participants in all three groups will complete 18 treatment sessions over six weeks at a frequency of three sessions per week. The active tDCS plus VR group will receive low-intensity tDCS at 1 mA for 20 minutes per session in combination with a structured VR-based rehabilitation programme. The VR programme will include progressively challenging activities directed toward postural control, balance, coordination, gait-related activity, and cognitive-motor integration.
Participants in the sham tDCS plus VR group will undergo the same electrode setup and VR rehabilitation programme. Sham stimulation will be delivered briefly at the beginning of the session to reproduce the initial sensations of stimulation without providing continued active cortical stimulation. Participants allocated to conventional physical therapy will receive a structured rehabilitation programme incorporating stretching, lower-limb strengthening, balance training, gait training, functional mobility exercises, and progressive task-specific practice.
Assessments will be conducted at baseline before the intervention (S0), after nine treatment sessions at the midpoint of the programme (S9), and following completion of 18 treatment sessions (S18).
The co-primary outcomes will be gait performance, assessed using the 10-Meter Walk Test, and self-esteem, assessed using the child version of the Rosenberg Self-Esteem Scale. Secondary outcome domains will include spasticity assessed using the Modified Tardieu Scale, gross motor function assessed using the Gross Motor Function Measure-88, functional mobility assessed using the Functional Mobility Scale, and functional independence assessed using the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT).
The study is intended to determine whether active tDCS provides an additional therapeutic effect when combined with VR rehabilitation beyond the effects associated with VR training and sham stimulation, while also comparing the technology-assisted intervention with conventional physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel intervention groups: active transcranial direct current stimulation combined with virtual reality rehabilitation, sham transcranial direct current stimulation combined with the same virtual reality rehabilitation, or conventional physical therapy. Each group will receive 18 treatment sessions over six weeks, with three sessions per week. Outcomes will be assessed at baseline, after nine sessions, and after 18 sessions.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Active tDCS + Virtual Reality | Experimental | Device: Active Transcranial Direct Current Stimulation, Behavioral: Virtual Reality RehabilitationParticipants will receive active transcranial direct current stimulation at 1 mA for 20 minutes combined with virtual reality rehabilitation, three sessions per week for six weeks, for a total of 18 sessions. |
| Sham Comparator: Sham tDCS + Virtual Reality | Sham comparator | Device: Sham Transcranial Direct Current Stimulation, Behavioral: Virtual Reality RehabilitationParticipants will receive sham transcranial direct current stimulation using the same electrode setup, with brief initial stimulation to mimic active tDCS, combined with the same virtual reality rehabilitation protocol, three sessions per week for six weeks. |
| Active Comparator: Conventional Physical Therapy | Active comparator | Behavioral: Conventional Physical TherapyParticipants will receive conventional physical therapy including stretching, strengthening, balance training, gait training, and functional mobility exercises, three sessions per week for six weeks. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosed with spastic cerebral palsy (spastic diplegia). Age 8-16 years. Gross Motor Function Classification System (GMFCS) levels I-III. Presence of mild to moderate lower-limb spasticity, defined as a Modified Tardieu Scale (MTS) score between 1 and 3 in at least one major lower-limb muscle group, such as the gastrocnemius, hamstrings, or hip adductors.
- Able to understand and follow verbal instructions. Parent or guardian provides informed consent and the child provides assent.
Key exclusion criteria (5 listed)
- History of seizures or epilepsy. Implanted metal or electronic devices, such as a pacemaker. Severe cognitive impairment that prevents comprehension of study tasks. Skin allergies, lesions, or other conditions affecting the electrode application sites.
- Current use of antispasticity medication that could directly influence spasticity outcomes.
- Botulinum toxin injection within the previous 3 months. Recent orthopedic surgery or change in medication regimen within the previous 5 days.
- Concurrent participation in alternative or adjunct therapies outside the study protocol.
- Refusal to participate or withdrawal of consent/assent.
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 |
|---|---|---|
| Active Transcranial Direct Current StimulationAlso: Active tDCSActive transcranial direct current stimulation will be delivered using saline-soaked sponge electrodes at an intensity of 1 mA for 20 minutes per session. Stimulation will be administered three times per week for six weeks, for a total of 18 sessions, concurrently with virtual reality rehabilitation. The stimulation montage will target the lower-limb motor cortical region with a supraorbital reference electrode. | Device | Experimental: Active tDCS + Virtual Reality |
| Sham Transcranial Direct Current StimulationAlso: Sham tDCSSham transcranial direct current stimulation will use the same electrode montage and setup as the active condition. Active current will be delivered only during the initial 30 seconds to reproduce the early sensory experience of stimulation, after which stimulation will be discontinued while the electrodes remain in place. Sham tDCS will be combined with the same virtual reality rehabilitation protocol as the active tDCS group. | Device | Sham Comparator: Sham tDCS + Virtual Reality |
| Virtual Reality RehabilitationAlso: Xbox Kinect-Based Virtual Reality TherapyVirtual reality rehabilitation will be delivered using a Microsoft Xbox console with Kinect motion tracking. The program will include progressive whole-body, balance, gait-related, coordination, navigation, and dual-task activities using Kinect Adventures. Training will progress through familiarization, cognitive-motor integration, and challenge/functional integration phases over six weeks. VR will be provided in both the active and sham tDCS groups for 18 sessions. | Behavioural | Experimental: Active tDCS + Virtual Reality, Sham Comparator: Sham tDCS + Virtual Reality |
| Conventional Physical TherapyAlso: CPTConventional physical therapy will be delivered for 30 minutes per session, three sessions per week for six weeks, for a total of 18 sessions. Treatment will progress from lower-limb stretching, supported balance and weight shifting to strengthening, motor-control exercises, gait initiation, overground gait training, obstacle negotiation, and functional mobility activities. Exercise difficulty and therapist support will be progressed according to participant tolerance and functional ability. | Behavioural | Active Comparator: Conventional Physical Therapy |
Primary outcome
10-Meter Walk Test Self-Selected Walking Velocity
Time frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Gait performance will be assessed using the 10-Meter Walk Test at a self-selected walking pace. Walking velocity will be expressed in meters per second (m/s), with higher values indicating faster walking performance. The measure will be collected at baseline, mid-intervention, and post-intervention.
Child Rosenberg Self-Esteem Scale Total Score
Time frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Global self-esteem will be assessed using the Child Rosenberg Self-Esteem Scale. The scale contains 10 items and produces a total score ranging from 0 to 30, with higher scores indicating greater self-esteem. The total score will be assessed at baseline, mid-intervention, and post-intervention.
7 secondary outcomes
Modified Tardieu Scale
Time frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
GMFM-88
Time frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Functional Mobility Scale - 5 m, 50 m, and 500 m
Time frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Pediatric Evaluation of Disability Inventory-Computer Adaptive Test Daily Activities Domain Scaled Score
Time frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Pediatric Evaluation of Disability Inventory-Computer Adaptive Test Mobility Domain Scaled Score
Time frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Pediatric Evaluation of Disability Inventory-Computer Adaptive Test Social/Cognitive Domain Scaled Score
Time frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Pediatric Evaluation of Disability Inventory-Computer Adaptive Test Responsibility Domain Scaled Score
Time frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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 23 Sep 2026.
- Background: PubMed 32981401Jung S, Song S, Lee D, Lee K, Lee G. Effects of Kinect Video Game Training on Lower Extremity Motor Function, Balance, and Gait in Adolescents with Spastic Diplegia Cerebral Palsy: A Pilot Randomized Controlled Trial. Dev Neurorehabil. 2021 Apr;24(3):159-165. doi: 10.1080/17518423.2020.1819458. Epub 2020 Sep 27.
- Background: PubMed 24112817Grecco LA, Duarte Nde A, de Mendonca ME, Pasini H, Lima VL, Franco RC, de Oliveira LV, de Carvalho Pde T, Correa JC, Collange NZ, Sampaio LM, Galli M, Fregni F, Oliveira CS. Effect of transcranial direct current stimulation combined with gait and mobility training on functionality in children with cerebral palsy: study protocol for a double-blind randomized controlled clinical trial. BMC Pediatr. 2013 Oct 11;13:168. doi: 10.1186/1471-2431-13-168.
- Background: PubMed 27644454Lazzari RD, Politti F, Belina SF, Collange Grecco LA, Santos CA, Dumont AJL, Lopes JBP, Cimolin V, Galli M, Santos Oliveira C. Effect of Transcranial Direct Current Stimulation Combined With Virtual Reality Training on Balance in Children With Cerebral Palsy: A Randomized, Controlled, Double-Blind, Clinical Trial. J Mot Behav. 2017 May-Jun;49(3):329-336. doi: 10.1080/00222895.2016.1204266. Epub 2016 Sep 20.
- Background: PubMed 25604912Collange Grecco LA, de Almeida Carvalho Duarte N, Mendonca ME, Galli M, Fregni F, Oliveira CS. Effects of anodal transcranial direct current stimulation combined with virtual reality for improving gait in children with spastic diparetic cerebral palsy: a pilot, randomized, controlled, double-blind, clinical trial. Clin Rehabil. 2015 Dec;29(12):1212-23. doi: 10.1177/0269215514566997. Epub 2015 Jan 20.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly because the study involves a pediatric clinical population and the consent and ethical approval were not designed for unrestricted external sharing of participant-level data. Aggregate and de-identified study results will be reported in the thesis and subsequent publications.
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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.
WAQAR AHMED AWAN, PROFESSOR study chair
RIPHAH INTERNATIONAL UNIVERSITY PAKISTAN
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcranial Direct Current Stimulation, Virtual Reality Rehabilitation and Conventional Physical Therapy in people with Spastic Diplegic Cerebral Palsy, run by Riphah International University at 2 sites 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 HASSAN R RAUF, MS PEDIATRIC PHYSICAL THERAPY (+923161504297, hassanrauf507@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-Meter Walk Test Self-Selected Walking Velocity (time frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)). 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?
On the ClinicalTrials.gov record for NCT07829796, which also lists 4 linked publications.
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 Sep 2026.